FDA Device Registration & Listing · Castel San Pietro Ticino, CH · Registration 3005180920
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2023-01-05 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2023-01-16 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2024-02-14 |
| NKG | Posterior Cervical Screw System | Orthopedic | Class 2 | 888.3075 | 2024-02-14 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2024-02-14 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2017-10-23 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3520 | 2017-04-17 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2017-03-06 |
| PML | Bone Cement, Posterior Screw Augmentation | Orthopedic | Class 2 | 888.3027 | 2024-06-13 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2024-06-13 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2024-06-13 |
| LLZ | System, Image Processing, Radiological | Radiology | Class 2 | 892.2050 | 2021-07-23 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2026-02-04 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2026-01-15 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-01-05 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2023-09-21 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2020-11-16 |
| NKG | Posterior Cervical Screw System | Orthopedic | Class 2 | 888.3075 | 2020-11-16 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2021-01-19 |
| SBF | Orthopedic Augmented Reality | Neurology | Class 2 | 882.4560 | 2026-01-12 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2020-02-06 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2021-03-02 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3670 | 2021-03-02 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3660 | 2021-03-02 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Orthopedic | Class 2 | 888.3690 | 2021-03-02 |
| FWX | Table, Operating-Room, Mechanical | General, Plastic Surgery | Class 1 | 878.4950 | 2008-02-11 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2020-03-04 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-07-23 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2013-11-05 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2017-05-25 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2017-05-25 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2017-05-25 |
| JDY | Evacuator, Vapor, Cement Monomer | Orthopedic | Class 1 | 888.4220 | 2022-01-11 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2026-06-12 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2011-03-29 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2011-03-29 |
| GET | Motor, Surgical Instrument, Pneumatic Powered | General, Plastic Surgery | Class 1 | 878.4820 | 2008-06-04 |
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2019-07-24 |
| PQC | Pedicle Screw Placement Guide | Orthopedic | Class 2 | 888.3070 | 2018-04-19 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2021-01-26 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2021-01-26 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2021-01-26 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2017-04-03 |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Orthopedic | Class 2 | 888.3360 | 2017-04-03 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2017-04-03 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2017-04-03 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2017-04-03 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2016-05-22 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2016-05-22 |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Orthopedic | Class 2 | 888.3360 | 2016-05-22 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2016-05-22 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2016-05-22 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2019-07-24 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| OAR | Injector, Vertebroplasty (Does Not Contain Cement) | Orthopedic | Class 1 | 888.4200 | 2010-03-30 |
| FLE | Sterilizer, Steam | General Hospital | Class 2 | 880.6880 | 2023-02-10 |
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | Class 2 | 888.3045 | 2010-03-30 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2009-06-03 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2009-06-03 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2008-02-11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2023-01-18 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2018-03-15 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2018-03-15 |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Orthopedic | Class 2 | 888.3360 | 2018-03-15 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2018-03-15 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2018-03-15 |
| SBF | Orthopedic Augmented Reality | Neurology | Class 2 | 882.4560 | 2020-10-27 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2019-07-24 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2017-08-02 |
| OUR | Sacroiliac Joint Fixation | Orthopedic | Class 2 | 888.3040 | 2017-08-02 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2017-08-02 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2021-06-10 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2021-02-12 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2023-11-10 |
| LLZ | System, Image Processing, Radiological | Radiology | Class 2 | 892.2050 | 2020-11-04 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2019-03-18 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2023-01-05 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2013-08-27 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2021-01-12 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2021-01-12 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2023-01-05 |
| HWQ | Passer | Orthopedic | Class 1 | 888.4540 | 2025-06-12 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2014-05-28 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Orthopedic | Class 2 | 888.3690 | 2018-12-10 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2018-12-10 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3660 | 2018-12-10 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3670 | 2018-12-10 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2017-09-18 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2011-03-29 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2021-09-22 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2021-09-22 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2023-01-05 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2011-06-14 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2010-01-22 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2010-01-22 |
| LOD | Bone Cement | Orthopedic | Class 2 | 888.3027 | 2021-10-13 |
| FDG | Retractor, Fiberoptic | Gastroenterology, Urology | Class 1 | 876.4530 | 2018-05-08 |
| GDF | Guide, Needle, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2017-06-09 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2025-06-20 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-06-20 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2025-06-20 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-06-20 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Orthopedic | Class 2 | 888.3360 | 2025-06-20 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2013-10-21 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2013-10-21 |
| PQC | Pedicle Screw Placement Guide | Orthopedic | Class 2 | 888.3070 | 2020-10-05 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2013-05-21 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2012-06-12 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2012-06-12 |
| MBB | Bone Cement, Antibiotic | Orthopedic | Class 2 | 888.3027 | 2021-10-13 |
| LOD | Bone Cement | Orthopedic | Class 2 | 888.3027 | 2021-10-13 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2020-01-29 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2009-01-22 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2009-01-22 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | Class 2 | 888.3080 | 2020-11-07 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3670 | 2021-03-26 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3660 | 2021-03-26 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2021-03-26 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2026-04-29 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-04-29 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2026-04-29 |
| OCJ | Spinal Channeling Instrument, Vertebroplasty | Orthopedic | Class 1 | 888.4540 | 2023-01-05 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2023-01-21 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2016-07-21 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2014-06-16 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3510 | 2021-03-02 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2021-03-02 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2020-03-13 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2017-08-08 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2017-08-08 |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Orthopedic | Class 2 | 888.3360 | 2017-08-08 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2017-08-08 |
| NKG | Posterior Cervical Screw System | Orthopedic | Class 2 | 888.3075 | 2017-08-01 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2017-08-01 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2018-12-04 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2012-10-22 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2012-10-22 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2022-02-03 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2018-10-03 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2015-11-02 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2015-11-02 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2015-11-02 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2015-11-02 |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Orthopedic | Class 2 | 888.3360 | 2015-11-02 |
| OUR | Sacroiliac Joint Fixation | Orthopedic | Class 2 | 888.3040 | 2019-12-03 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2019-12-03 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2019-12-03 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2026-02-27 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2026-02-27 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2020-02-10 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2020-02-10 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2020-02-10 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2017-08-21 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2021-05-14 |
| HWP | Punch, Femoral Neck | Orthopedic | Class 1 | 888.4540 | 2023-01-05 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2020-02-19 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-09-22 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-09-22 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2013-12-26 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2013-12-26 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2013-12-26 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2013-12-26 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-12-26 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2019-09-13 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2022-03-10 |
| SBF | Orthopedic Augmented Reality | Neurology | Class 2 | 882.4560 | 2022-03-10 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | Orthopedic | Class 2 | 888.3030 | 2022-03-10 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2023-01-05 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2022-10-25 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3660 | 2018-04-05 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3670 | 2018-04-05 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2018-04-05 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2012-08-01 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3660 | 2017-08-16 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | Neurology | Class 2 | 882.4800 | 2014-10-27 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2022-04-12 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2022-04-12 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2022-04-12 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2022-04-12 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2019-07-24 |
| LLZ | System, Image Processing, Radiological | Radiology | Class 2 | 892.2050 | 2023-01-21 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2010-04-16 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2018-11-30 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2018-11-30 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2018-11-30 |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Orthopedic | Class 2 | 888.3360 | 2018-11-30 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2018-11-30 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2019-07-24 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Orthopedic | Class 2 | 888.3030 | 2025-06-11 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2011-03-28 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2016-12-21 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2016-12-21 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2016-12-21 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2016-12-21 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2016-12-21 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2019-03-21 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2023-06-11 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2018-08-24 |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Orthopedic | Class 2 | 888.3360 | 2019-05-31 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2019-05-31 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2019-05-31 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2019-05-31 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2019-05-31 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2025-06-11 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2025-06-11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2020-12-11 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3510 | 2016-12-21 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2016-12-21 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2020-12-28 |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Orthopedic | Class 2 | 888.3360 | 2020-12-28 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2020-12-28 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2020-12-28 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2020-12-28 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2020-12-28 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2023-04-18 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2024-05-24 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2012-10-09 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2020-10-05 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2019-05-29 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2021-04-28 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2021-04-28 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2021-04-28 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2019-11-22 |
| SBF | Orthopedic Augmented Reality | Neurology | Class 2 | 882.4560 | 2021-11-05 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3520 | 2021-11-16 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2013-12-26 |
| JDQ | Cerclage, Fixation | Orthopedic | Class 2 | 888.3010 | 2024-05-04 |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Orthopedic | Class 2 | 888.3360 | 2011-08-17 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2014-01-24 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2014-01-24 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2014-02-02 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| SBF | Orthopedic Augmented Reality | Neurology | Class 2 | 882.4560 | 2023-10-30 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2017-12-08 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2017-12-08 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2017-12-08 |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Orthopedic | Class 2 | 888.3360 | 2017-12-08 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2017-12-08 |
| SBF | Orthopedic Augmented Reality | Neurology | Class 2 | 882.4560 | 2025-08-04 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 2025-06-12 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2017-11-29 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2017-11-29 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2025-06-11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2019-06-05 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2022-05-24 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2022-05-24 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2015-05-07 |
| SBF | Orthopedic Augmented Reality | Neurology | Class 2 | 882.4560 | 2025-09-05 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2020-01-28 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2020-01-28 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2020-01-28 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2020-08-12 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3670 | 2020-08-12 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Orthopedic | Class 2 | 888.3690 | 2020-08-12 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2010-03-05 |
| LLZ | System, Image Processing, Radiological | Radiology | Class 2 | 892.2050 | 2021-02-19 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2024-04-26 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | Orthopedic | Class 2 | 888.3030 | 2024-04-26 |
| SBF | Orthopedic Augmented Reality | Neurology | Class 2 | 882.4560 | 2024-04-26 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2011-03-23 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2011-03-23 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2023-01-16 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2021-12-22 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2021-12-22 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2008-10-31 |
| HTY | Pin, Fixation, Smooth | Orthopedic | Class 2 | 888.3040 | 2014-09-12 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2014-09-12 |
| JDW | Pin, Fixation, Threaded | Orthopedic | Class 2 | 888.3040 | 2014-09-12 |
| SBF | Orthopedic Augmented Reality | Neurology | Class 2 | 882.4560 | 2023-07-22 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | Orthopedic | Class 2 | 888.3030 | 2023-07-22 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2023-07-22 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2022-07-22 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2022-07-22 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Orthopedic | Class 2 | 888.3030 | 2025-06-11 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | Orthopedic | Class 2 | 888.3030 | 2025-12-03 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2016-01-19 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2016-01-19 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2016-01-19 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2016-01-19 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2016-01-19 |
| HRT | Stripper, Surgical | Orthopedic | Class 1 | 888.4540 | 2025-06-12 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| GFF | Bur, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4820 | 2019-07-11 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2012-06-11 |
| LLZ | System, Image Processing, Radiological | Radiology | Class 2 | 892.2050 | 2025-02-03 |
| QHE | Shoulder Arthroplasty Implantation System | Orthopedic | Class 2 | 888.3660 | 2025-02-03 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3660 | 2025-02-03 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2017-10-20 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2023-01-05 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2020-01-06 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2020-01-06 |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Orthopedic | Class 2 | 888.3360 | 2020-01-06 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2020-01-06 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2020-01-06 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2020-01-06 |
| HWA | Impactor | Orthopedic | Class 1 | 888.4540 | 2023-01-05 |
| LZN | Cement Obturator | General, Plastic Surgery | Class 2 | 878.3300 | 2023-02-21 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2022-11-26 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2026-01-30 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2026-01-30 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2014-08-19 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2014-08-19 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2014-08-19 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2014-08-19 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2014-08-19 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2019-10-03 |
| PQC | Pedicle Screw Placement Guide | Orthopedic | Class 2 | 888.3070 | 2021-04-06 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2017-03-16 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2011-12-22 |
| NKG | Posterior Cervical Screw System | Orthopedic | Class 2 | 888.3075 | 2022-04-26 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2022-04-26 |
| LLZ | System, Image Processing, Radiological | Radiology | Class 2 | 892.2050 | 2025-04-28 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2025-06-11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2022-05-05 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3520 | 2019-01-30 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2010-03-15 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2011-01-26 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2011-01-26 |
| SBF | Orthopedic Augmented Reality | Neurology | Class 2 | 882.4560 | 2021-05-12 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-04-24 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-04-24 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2011-03-29 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2021-04-20 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2021-04-20 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2021-04-20 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2011-02-15 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2011-02-15 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2008-02-11 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 2023-01-05 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-07-02 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2023-02-26 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2015-03-05 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2015-03-05 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2015-03-05 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2013-07-30 |
| JDK | Prosthesis, Hip, Cement Restrictor | General, Plastic Surgery | Class 2 | 878.3300 | 2022-11-23 |
| HWB | Extractor | Orthopedic | Class 1 | 888.4540 | 2023-01-05 |
| PQC | Pedicle Screw Placement Guide | Orthopedic | Class 2 | 888.3070 | 2023-07-22 |
| QSR | Sacroiliac Screw Placement Guide | Orthopedic | Class 2 | 888.3040 | 2023-07-22 |
| QSR | Sacroiliac Screw Placement Guide | Orthopedic | Class 2 | 888.3040 | 2022-05-24 |
| PQC | Pedicle Screw Placement Guide | Orthopedic | Class 2 | 888.3070 | 2022-05-24 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2017-12-13 |
| NDN | Cement, Bone, Vertebroplasty | Orthopedic | Class 2 | 888.3027 | 2024-06-14 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2023-01-05 |
| KIH | Dispenser, Cement | Orthopedic | Class 1 | 888.4200 | 2022-01-11 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2020-09-18 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2020-09-18 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2020-09-18 |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Orthopedic | Class 2 | 888.3360 | 2020-09-18 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2026-05-06 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2014-08-18 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2014-08-18 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2014-08-18 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2014-08-18 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2014-08-18 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2011-06-01 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2023-02-10 |
| HTO | Reamer | Orthopedic | Class 1 | 888.4540 | 2023-01-05 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2012-02-29 |
| GEY | Motor, Surgical Instrument, Ac-Powered | General, Plastic Surgery | Class 1 | 878.4820 | 2025-07-02 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3650 | 2020-03-25 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Orthopedic | Class 2 | 888.3690 | 2020-03-25 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3660 | 2020-03-25 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2020-03-25 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-11 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | Orthopedic | Class 2 | 888.3030 | 2023-05-31 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2020-01-09 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2020-01-09 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2020-04-30 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2020-04-30 |
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | Class 2 | 888.3045 | 2010-03-30 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2022-08-24 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2022-08-24 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2021-01-13 |
| OUR | Sacroiliac Joint Fixation | Orthopedic | Class 2 | 888.3040 | 2021-01-13 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2021-01-13 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2018-08-23 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3007319107 | PARCUS MEDICAL , L.L.C. | Sarasota, FL, US |
| 3008110533 | MEDACTA INTERNATIONAL SA | Rancate Ticino, CH |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K163363 | Surgtech, Inc. | SurgTech Thoracolumbosacral (TLS) Posterior Fixation System | 2017-04-05 |
| K252461 | Spinal Resources, Inc. | Swedge Pedicle Screw Fixation System Bezier Rod | 2026-01-13 |
| K140696 | Pioneer Surgical Technology, Inc. | STREAMLINE TL SPINAL FIXATION SYSTEM | 2014-04-10 |
| K141398 | Medicrea International SA | PASS LP SPINAL SYSTEM | 2015-01-09 |
| K160980 | Spineology, Inc. | Threshold Pedicular Fixation System, Palisade Pedicular Fixation System | 2016-05-26 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0034-2012 | X Spine Systems Inc | 1 | Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144
The Axle Torque Driver Handle is used to lock the set screw into the locking plate. |
| Z-0001-2013 | Synthes USA HQ, Inc. | 2 | MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine.
The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). |
| Z-0004-2008 | Abbott Spine | 2 | PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50. |
| Z-0005-2008 | Abbott Spine | 2 | PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60. |
| Z-0020-06 | Pioneer Surgical Technology | 2 | Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 8040179 | BASHIR JAMIL & BROTHERS (PVT.), LTD. | Sialkot Punjab, PK |
| 8010298 | RUDOLF MEDICAL GMBH + CO. KG | FRIDINGEN Baden-Wurttemberg, DE |
| 3015895045 | Sklar Corporation - Warehouse | Salisbury, MD, US |
| 1038671 | EXACTECH, INC. | GAINESVILLE, FL, US |
| 9680735 | HERMANN MUELLER Medizintechnik GmbH | TUTTLINGEN Baden-Wurttemberg, DE |
3005180920 when referencing this establishment in official correspondence.