FDA Device Registration & Listing · Bloomington, MN, US · Registration 3003477135
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2015-01-10 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2015-01-10 |
| OJH | Orthopedic Tray | General, Plastic Surgery | Class 1 | 878.4800 | 2017-05-08 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | Orthopedic | Class 2 | 888.3060 | 2019-01-15 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2019-01-15 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2024-12-10 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2024-12-10 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2024-12-10 |
| KWH | Prosthesis, Toe, Constrained, Polymer | Orthopedic | Class 2 | 888.3720 | 2013-12-27 |
| ETN | Stimulator, Nerve | Ear, Nose, Throat | Class 2 | 874.1820 | 2024-12-09 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2024-12-10 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2024-12-10 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2012-12-09 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2012-12-09 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2016-10-24 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | Class 2 | 892.1750 | 2018-12-31 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2012-12-08 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2012-12-08 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2017-05-02 |
| HXI | Passer, Wire, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2013-12-27 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2015-09-08 |
| HBW | Fastener, Plate, Cranioplasty | Neurology | Class 2 | 882.5360 | 2015-11-17 |
| GXR | Cover, Burr Hole | Neurology | Class 2 | 882.5250 | 2015-11-17 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | Neurology | Class 2 | 882.5320 | 2015-11-17 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2016-10-31 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2024-12-10 |
| LXN | Probe, Test, Heart-Valve | Cardiovascular | Class 1 | 870.4500 | 2012-12-09 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2019-01-15 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2019-01-15 |
| LZJ | Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained | Unknown | Class U | N/A | 2014-03-31 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2015-12-02 |
| OMX | High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis | Unknown | Class f | N/A | 2014-03-26 |
| NEG | Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis | Unknown | Class 3 | N/A | 2014-03-26 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2015-12-02 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2015-12-02 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2017-11-02 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Orthopedic | Class 2 | 888.3358 | 2015-01-11 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3360 | 2015-01-11 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2015-01-11 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2012-11-26 |
| KWH | Prosthesis, Toe, Constrained, Polymer | Orthopedic | Class 2 | 888.3720 | 2013-12-27 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2015-12-02 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2015-12-02 |
| IYE | Accelerator, Linear, Medical | Radiology | Class 2 | 892.5050 | 2015-11-16 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | Orthopedic | Class 2 | 888.3770 | 2014-03-26 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Orthopedic | Class 2 | 888.3730 | 2024-12-06 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2012-10-05 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | Class 2 | 892.1750 | 2016-10-28 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2024-12-09 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2024-12-16 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2016-11-09 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2016-11-09 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2016-11-09 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2016-11-09 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2016-11-09 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 2013-12-27 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2018-11-06 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2024-12-09 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2012-12-15 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2024-12-18 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2024-12-09 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2012-12-08 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2015-12-02 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2015-12-02 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2018-11-02 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3110 | 2024-12-17 |
| OWB | Interventional Fluoroscopic X-Ray System | Radiology | Class 2 | 892.1650 | 2015-11-16 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | Radiology | Class 2 | 892.1650 | 2015-11-16 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | Radiology | Class 2 | 892.1650 | 2015-11-16 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Orthopedic | Class 2 | 888.3730 | 2012-11-25 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2019-01-15 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2013-12-27 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2013-12-27 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2013-12-26 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2018-11-06 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2016-10-27 |
| GFG | Bit, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2016-10-27 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2016-10-27 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2016-10-27 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Hematology | Class 2 | 864.9245 | 2017-11-07 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | Class 2 | 892.1750 | 2018-12-31 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2024-12-10 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2019-01-15 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2019-01-15 |
| IKE | Transducer, Miniature Pressure | Physical Medicine | Class 1 | 890.1615 | 2015-01-11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2021-11-09 |
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | Unknown | Class 3 | N/A | 2017-11-22 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | Orthopedic | Class 2 | 888.3170 | 2014-03-26 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2017-12-07 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2015-12-02 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2015-12-02 |
| LYA | Splint, Intranasal Septal | Ear, Nose, Throat | Class 1 | 874.4780 | 2017-12-11 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2016-03-08 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2012-12-08 |
| JDZ | Mixer, Cement, For Clinical Use | Orthopedic | Class 1 | 888.4210 | 2018-11-06 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2024-12-09 |
| EZW | Stimulator, Electrical, Implantable, For Incontinence | Gastroenterology, Urology | Class 3 | 876.5270 | 2024-12-10 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2012-12-08 |
| GXI | Probe, Radiofrequency Lesion | Neurology | Class 2 | 882.4725 | 2017-10-24 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2019-01-15 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2019-01-15 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2019-01-15 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2016-11-16 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2016-11-16 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2016-11-16 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2016-11-16 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2016-11-16 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2016-11-16 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2012-12-08 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2012-12-08 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2013-12-27 |
| QON | Implanted Electrical Device Intended For Treatment Of Fecal Incontinence | Gastroenterology, Urology | Class 3 | 876.5270 | 2024-12-10 |
| OUR | Sacroiliac Joint Fixation | Orthopedic | Class 2 | 888.3040 | 2013-12-26 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2024-12-09 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2016-11-16 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2016-11-16 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2016-11-16 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2016-11-16 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2016-11-16 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2016-11-16 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2019-01-15 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2019-01-15 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2018-11-05 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2018-11-05 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Orthopedic | Class 2 | 888.3358 | 2018-11-05 |
| HTY | Pin, Fixation, Smooth | Orthopedic | Class 2 | 888.3040 | 2021-02-16 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2018-11-01 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2024-12-18 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2024-12-18 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2024-12-18 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2024-12-18 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | Orthopedic | Class 2 | 888.3800 | 2024-12-09 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2012-12-09 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2015-12-02 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2015-12-02 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Orthopedic | Class 2 | 888.3690 | 2014-03-26 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3660 | 2014-03-26 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2015-09-08 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2015-09-08 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2015-09-08 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2015-09-08 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2015-09-08 |
| GYK | Instrument, Shunt System Implantation | Neurology | Class 1 | 882.4545 | 2017-12-04 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2015-01-11 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2015-01-11 |
| KIH | Dispenser, Cement | Orthopedic | Class 1 | 888.4200 | 2014-04-09 |
| OUR | Sacroiliac Joint Fixation | Orthopedic | Class 2 | 888.3040 | 2024-12-09 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3110 | 2024-12-10 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2019-01-15 |
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | Class 2 | 888.3045 | 2013-12-27 |
| OWI | Bone Fixation Cerclage, Sublaminar | Orthopedic | Class 2 | 888.3010 | 2015-12-03 |
| NKG | Posterior Cervical Screw System | Orthopedic | Class 2 | 888.3075 | 2019-01-15 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2019-01-15 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2013-12-26 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2013-12-26 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2013-12-26 |
| KWH | Prosthesis, Toe, Constrained, Polymer | Orthopedic | Class 2 | 888.3720 | 2015-10-13 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2015-10-26 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2018-11-06 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2016-10-27 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3360 | 2017-11-02 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2017-11-02 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Orthopedic | Class 2 | 888.3358 | 2017-11-02 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2017-11-02 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2017-11-03 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2017-11-03 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2015-12-02 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2015-12-02 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3110 | 2024-12-17 |
| LLZ | System, Image Processing, Radiological | Radiology | Class 2 | 892.2050 | 2016-10-28 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | Class 2 | 892.1750 | 2016-10-28 |
| KTI | Bronchoscope Accessory | Ear, Nose, Throat | Class 2 | 874.4680 | 2016-10-28 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2015-11-25 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2015-11-25 |
| LXB | Hearing Aid, Bone Conduction | Ear, Nose, Throat | Class 2 | 874.3302 | 2015-01-11 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2019-01-15 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2024-12-05 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2024-12-05 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2018-12-10 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2016-10-27 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | Class 2 | 888.3020 | 2024-12-17 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2015-09-08 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2015-09-08 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2015-09-08 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2015-09-08 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2015-09-08 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2016-10-31 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2016-10-31 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Orthopedic | Class 2 | 888.3730 | 2024-12-06 |
| PLA | Esophageal Thermal Regulation And Gastric Suctioning Device | Cardiovascular | Class 2 | 870.5910 | 2024-06-10 |
| QXV | Temperature Regulation Device For Esophageal Protection During Cardiac Ablation | Cardiovascular | Class 2 | 870.5720 | 2024-06-10 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2019-01-15 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | Class 2 | 888.3020 | 2012-11-25 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2018-11-06 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2024-12-09 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2024-12-09 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2024-12-09 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2013-12-26 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2019-01-15 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2012-12-10 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | Class 2 | 888.3020 | 2014-03-26 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2018-12-04 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2019-01-15 |
| FGY | Cannula, Injection | General, Plastic Surgery | Class 1 | 878.4200 | 2015-01-11 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2018-11-06 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2016-01-13 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2016-01-13 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2015-12-02 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2015-12-02 |
| GFI | Osteotome, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2017-11-28 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2024-12-18 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | Orthopedic | Class 2 | 888.3050 | 2017-10-31 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2015-01-11 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2015-01-11 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3360 | 2015-01-11 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Orthopedic | Class 2 | 888.3358 | 2015-01-11 |
| HTR | Rasp | General, Plastic Surgery | Class 1 | 878.4800 | 2016-10-27 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2015-01-11 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2015-11-03 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2015-12-03 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2016-10-28 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2018-12-10 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2012-12-08 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2012-12-15 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2012-12-08 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2018-12-04 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2018-12-04 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 2018-12-04 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2018-12-04 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2018-12-04 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2018-12-04 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2018-12-04 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2018-12-04 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2015-11-04 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2017-12-05 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2017-12-05 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2013-12-27 |
| OUG | Medical Device Data System | General Hospital | Class 1 | 880.6310 | 2012-12-15 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2018-11-21 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2016-10-31 |
| OUR | Sacroiliac Joint Fixation | Orthopedic | Class 2 | 888.3040 | 2015-12-01 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2012-11-25 |
| MJW | Prosthesis, Subtalar, Plug, Polymer | Orthopedic | Class 2 | 888.3040 | 2013-12-27 |
| PST | Aortic Annuloplasty Ring | Cardiovascular | Class 2 | 870.3800 | 2017-11-22 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2024-12-09 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2024-12-09 |
| KPS | System, Tomography, Computed, Emission | Radiology | Class 2 | 892.1200 | 2012-10-05 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2015-09-08 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2015-09-08 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2015-09-08 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2015-09-08 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2015-09-08 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2024-12-10 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2024-12-10 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2014-04-09 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2015-11-16 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2019-01-15 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3520 | 2012-11-25 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3530 | 2012-11-25 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2017-11-28 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2024-12-09 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2019-01-15 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2019-01-15 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2019-01-15 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2019-01-15 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2019-01-15 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2019-01-15 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2018-11-06 |
| NKG | Posterior Cervical Screw System | Orthopedic | Class 2 | 888.3075 | 2018-11-06 |
| NPJ | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2015-12-03 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3520 | 2015-12-03 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3530 | 2015-12-03 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2015-12-03 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3540 | 2015-12-03 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2018-11-21 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2018-11-21 |
| KWH | Prosthesis, Toe, Constrained, Polymer | Orthopedic | Class 2 | 888.3720 | 2013-12-27 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2016-10-26 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2024-12-09 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2012-12-22 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | Class 2 | 892.1750 | 2015-01-11 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2017-11-28 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2024-12-10 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2014-03-25 |
| KWH | Prosthesis, Toe, Constrained, Polymer | Orthopedic | Class 2 | 888.3720 | 2012-11-25 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2019-01-15 |
| NEG | Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis | Unknown | Class 3 | N/A | 2014-03-26 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2018-11-05 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2018-11-05 |
| HTY | Pin, Fixation, Smooth | Orthopedic | Class 2 | 888.3040 | 2015-12-02 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2012-12-08 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2012-12-08 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2024-12-09 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2012-12-08 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2024-12-10 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2024-12-10 |
| LZP | Aid, Surgical, Viscoelastic | Ophthalmic | Class 3 | 886.4275 | 2024-12-09 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2019-01-15 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2019-01-15 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2018-12-31 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2012-12-10 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2012-12-10 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2015-09-08 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2015-09-08 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3110 | 2024-12-17 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2024-12-09 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | Orthopedic | Class 2 | 888.3060 | 2024-12-09 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2018-11-05 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2018-11-05 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Orthopedic | Class 2 | 888.3358 | 2018-11-05 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3360 | 2018-11-05 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2018-11-05 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2018-11-21 |
| PLF | Bone Wedge | Orthopedic | Class 2 | 888.3030 | 2018-11-21 |
| QSZ | Absorbable Synthetic Wound Dressing | Unknown | Class U | N/A | 2018-11-29 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3110 | 2015-11-03 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2024-12-18 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2024-12-05 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2024-12-05 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2019-01-15 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2019-01-15 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2019-01-15 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2012-12-15 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2014-11-24 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2024-12-09 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2013-12-27 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2015-10-23 |
| KDD | Kit, Surgical Instrument, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2018-12-31 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2024-12-09 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2024-12-09 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2012-10-05 |
| MKY | System, Skin Closure | General, Plastic Surgery | Class 1 | 878.4320 | 2012-12-09 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2018-11-02 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2024-12-05 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2024-12-05 |
| HTY | Pin, Fixation, Smooth | Orthopedic | Class 2 | 888.3040 | 2016-11-02 |
| GXI | Probe, Radiofrequency Lesion | Neurology | Class 2 | 882.4725 | 2017-10-24 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2024-12-10 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2018-11-21 |
| HWT | Template | Orthopedic | Class 1 | 888.4800 | 2014-12-29 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2015-10-23 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Orthopedic | Class 2 | 888.3358 | 2015-10-23 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2015-10-23 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2024-12-09 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2024-12-09 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2012-12-08 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2018-10-31 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2019-01-15 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | Class 2 | 876.5130 | 2013-01-05 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3110 | 2024-12-17 |
| JDQ | Cerclage, Fixation | Orthopedic | Class 2 | 888.3010 | 2015-11-25 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2018-11-06 |
| GXZ | Electrode, Needle | Neurology | Class 2 | 882.1350 | 2024-12-09 |
| KXE | Prosthesis, Wrist, Hemi-, Ulnar | Orthopedic | Class 2 | 888.3810 | 2014-03-26 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2018-11-06 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2019-01-15 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Orthopedic | Class 2 | 888.3358 | 2024-12-05 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2024-12-05 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2024-12-05 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2024-12-05 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2013-12-26 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2013-12-26 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2017-12-05 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2024-12-09 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2016-10-26 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2016-10-26 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2012-11-25 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2024-12-09 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2024-12-09 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2024-12-09 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2024-12-09 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2024-12-09 |
| OUR | Sacroiliac Joint Fixation | Orthopedic | Class 2 | 888.3040 | 2024-12-09 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2015-01-11 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2012-10-05 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2012-11-26 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2015-01-11 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2024-12-09 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2024-12-10 |
| FQO | Table, Operating-Room, Ac-Powered | General, Plastic Surgery | Class 1 | 878.4960 | 2024-12-09 |
| KWH | Prosthesis, Toe, Constrained, Polymer | Orthopedic | Class 2 | 888.3720 | 2013-12-27 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2017-10-26 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | Class 2 | 888.3060 | 2017-10-26 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2017-10-26 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3110 | 2024-12-17 |
| HAO | Instrument, Surgical, Non-Powered | Neurology | Class 1 | 882.4535 | 2024-12-09 |
| MRU | Implanted Subcortical Electrical Stimulator (Motor Disorders) | Unknown | Class f | N/A | 2021-06-08 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2016-10-24 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2012-10-23 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2012-12-08 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2015-11-03 |
| OUR | Sacroiliac Joint Fixation | Orthopedic | Class 2 | 888.3040 | 2024-12-09 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2024-12-09 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2024-12-09 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2024-12-18 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2024-12-18 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2024-12-18 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2024-12-18 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2019-01-15 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2019-01-15 |
| PST | Aortic Annuloplasty Ring | Cardiovascular | Class 2 | 870.3800 | 2017-11-22 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2016-11-16 |
| GDF | Guide, Needle, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2013-12-27 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2013-12-26 |
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | Class 2 | 888.3045 | 2018-11-08 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Orthopedic | Class 2 | 888.3358 | 2024-12-05 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2024-12-05 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2024-12-05 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2024-12-05 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3360 | 2024-12-05 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2012-12-09 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Orthopedic | Class 2 | 888.3358 | 2012-12-09 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3360 | 2012-12-09 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2012-11-25 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3110 | 2024-12-10 |
| OJP | Orthopedic Computer Controlled Surgical System | Neurology | Class 2 | 882.4560 | 2012-12-08 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2012-12-08 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2024-12-09 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2012-10-05 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2024-12-05 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2024-12-05 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2024-12-05 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2019-01-15 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2019-01-15 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2022-02-14 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2015-01-11 |
| HWX | Tap, Bone | Orthopedic | Class 1 | 888.4540 | 2024-12-10 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | Orthopedic | Class 2 | 888.3170 | 2024-12-09 |
| NHL | Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | Unknown | Class 3 | N/A | 2021-06-08 |
| MHY | Stimulator, Electrical, Implanted, For Parkinsonian Tremor | Unknown | Class 3 | N/A | 2021-06-08 |
| PJS | Stimulator, Electrical, Implanted, For Essential Tremor | Unknown | Class 3 | N/A | 2021-06-08 |
| MBX | Stimulator, Thalamic, Epilepsy, Implanted | Unknown | Class 3 | N/A | 2021-06-08 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2017-11-02 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2017-11-28 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2012-12-08 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3520 | 2012-11-25 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3530 | 2012-11-25 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2012-12-08 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2012-12-08 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2013-12-26 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2018-12-05 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2015-11-03 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2018-11-26 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2018-11-26 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2023-08-09 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2023-08-09 |
| KCJ | Applicator, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2012-11-25 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2018-10-30 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2024-12-16 |
| GXD | Generator, Lesion, Radiofrequency | Neurology | Class 2 | 882.4400 | 2017-10-24 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2010-09-20 |
| NBH | Accessories, Arthroscopic | Orthopedic | Class 1 | 888.1100 | 2016-10-31 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2015-01-11 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2015-01-11 |
No official correspondent registered.
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3014596751 | Quality Tech Services, LLC | Shakopee, MN, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K223430 | Life Spine, Inc. | ProLift Micro Expandable Spacer System | 2023-05-04 |
| K102293 | Globus Medical, Inc. | CALIBER SPACER | 2011-01-05 |
| K193541 | Nu Vasive, Incorporated | NuVasive Cohere Thoracolumbar Interbody System | 2020-03-30 |
| K080401 | Advanced Medical Technologies AG | SHELL CAGE, WAVE CAGE, LOOP CAGE | 2008-05-09 |
| K200084 | Zavation Medical Products, LLC | Zavation IBF System | 2020-10-19 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0014-2014 | Synthes USA HQ, Inc. | 2 | Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle. |
| Z-0026-2013 | Orthohelix Surgical Designs Inc | 2 | OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS
The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle. |
| Z-0026-2016 | Ortho Solutions Inc 330 Franklin Tnpk | 2 | Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile
Orthopaedic Bone Screw |
| Z-0027-2013 | Orthohelix Surgical Designs Inc | 2 | OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS
The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle. |
| Z-0043-2018 | MicroPort Orthopedics Inc. | 2 | MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R
Product Usage:
MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3021588295 | XYRESIC LLC | Jackson, MI, US |
| 3017936978 | CARLSMED, INC. | Carlsbad, CA, US |
| 3016050940 | Olive Branch Distribution Center | Olive Branch, MS, US |
| 2134947 | GAUTHIER BIOMEDICAL, INC. | Grafton, WI, US |
| 1526534 | Sterigenics US, LLC | Lewis Center, OH, US |
3003477135 when referencing this establishment in official correspondence.