FDA Device Registration & Listing · Lititz, PA, US · Registration 3010120148
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| NKG | Posterior Cervical Screw System | Orthopedic | Class 2 | 888.3075 | 2018-12-26 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2018-12-26 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-01-13 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-01-13 |
| NKG | Posterior Cervical Screw System | Orthopedic | Class 2 | 888.3075 | 2025-01-13 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-02-01 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-02-01 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2013-02-01 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2013-02-01 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2013-02-01 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2013-02-01 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | Orthopedic | Class 2 | 888.3050 | 2018-12-26 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-01-13 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2025-01-13 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| NDN | Cement, Bone, Vertebroplasty | Orthopedic | Class 2 | 888.3027 | 2013-02-01 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2013-02-01 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-01-13 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2025-01-13 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-02-01 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2013-02-01 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-02-01 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | Class 2 | 888.3070 | 2013-02-01 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2013-02-01 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2013-02-01 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2013-02-01 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-01-13 |
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | Class 2 | 888.3045 | 2025-01-13 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2025-01-13 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-01-13 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-01-13 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2025-01-13 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-01-13 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2025-01-13 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-01-13 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2013-02-01 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2013-02-01 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2013-02-01 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2013-02-01 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-02-01 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2025-01-13 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2019-12-24 |
| OUR | Sacroiliac Joint Fixation | Orthopedic | Class 2 | 888.3040 | 2019-12-24 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | Orthopedic | Class 2 | 888.3050 | 2018-12-26 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-01-13 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2025-01-13 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-01-13 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | Class 2 | 870.2300 | 2025-01-13 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2013-02-01 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2018-12-26 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2018-12-26 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2018-12-26 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2018-12-26 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2018-12-26 |
| DSI | Detector And Alarm, Arrhythmia | Cardiovascular | Class 2 | 870.1025 | 2025-01-13 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2013-02-01 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-01-13 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2025-01-13 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2025-01-13 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2025-01-13 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2013-02-01 |
| FIP | Subsystem, Water Purification | Gastroenterology, Urology | Class 2 | 876.5665 | 2025-01-13 |
| PEK | Spinous Process Plate | Orthopedic | Class 2 | 888.3050 | 2018-12-26 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-01-13 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-01-13 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | Orthopedic | Class 2 | 888.3050 | 2025-01-13 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K161478 | Xenco Medical, LLC | Xenco Medical Posterior Cervical System | 2016-09-06 |
| K963639 | Acromed Corp. | ACROMED PEDICLE SCREW | 1996-11-14 |
| K260601 | Blue Belt Technologies, Inc. | REAL INTELLIGENCE CORI | 2026-03-26 |
| 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 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0026-2011 | Zimmer Inc. | 2 | SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S |
| Z-0027-2011 | Zimmer Inc. | 2 | SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M |
| Z-0028-2011 | Zimmer Inc. | 2 | SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L |
| Z-0029-2011 | Zimmer Inc. | 2 | SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL |
| Z-0030-2011 | Zimmer Inc. | 2 | SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3043543260 | FERRY MACHINE CORPORATION | Oakland, NJ, US |
| 3015831087 | Jabil Switzerland Manufacturing GmbH (Le Locle) | Le Locle Neuchatel, CH |
| 3008285983 | L&K BIOMED CO.,LTD. | Yongin-SI Gyeonggi, KR |
| 3006217744 | COULOT DECOLLETAGE | CHATELLERAULT Vienne, FR |
| 3010531060 | OSSEUS FUSION SYSTEMS LLC | Dallas, TX, US |
3010120148 when referencing this establishment in official correspondence.