Company · US
Zimmer Biomet Spine, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2021. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 7 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 |
| OLO | Orthopedic Stereotaxic Instrument | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 |
| LYQ | Accessories, Fixation, Spinal Intervertebral Body | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 |
| PGM | Growing Rod System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 27, 2021 | K212023 | Virage Navigation System Zimmer Biomet Spine, Inc. | OLO |
| May 4, 2021 | K203218 | CaP Spheres Pellet Pack Zimmer Biomet Spine, Inc. | MQV |
| Apr 2, 2021 | K210275 | Polaris Spinal System Zimmer Biomet Spine, Inc. | NKB |
| Jan 28, 2021 | K203507 | Vitality® Spinal Fixation System Zimmer Biomet Spine, Inc. | NKB |
| Oct 8, 2020 | K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Ad Zimmer Biomet Spine, Inc. | KWQ |
| Dec 2, 2019 | K191722 | Vital Navigation System Zimmer Biomet Spine, Inc. | OLO |
| Oct 29, 2019 | K192133 | Zimmer Biomet Universal Navigation System Zimmer Biomet Spine, Inc. | OLO |
| Oct 24, 2019 | K190556 | Zimmer Biomet Universal Navigation System Zimmer Biomet Spine, Inc. | OLO |
| Apr 8, 2019 | K183550 | Vitality® Spinal Fixation System Zimmer Biomet Spine, Inc. | NKB |
| Jan 15, 2019 | K181096 | Avenue P Cage System Zimmer Biomet Spine, Inc. | OVD |
| Mar 15, 2018 | K180227 | Polaris Spinal Growth System Zimmer Biomet Spine, Inc. | PGM |
| Feb 12, 2018 | K171495 | Zyston Strut Open Titanium Spacer System Zimmer Biomet Spine, Inc. | MAX |
| Sep 27, 2017 | K172275 | Vitality® Spinal Fixation System, Vitality®+ Power Instrument System Zimmer Biomet Spine, Inc. | NKB |
| Jul 14, 2017 | K171907 | Vitality® Spinal Fixation System Zimmer Biomet Spine, Inc. | NKB |
| Feb 28, 2017 | K163543 | Biomet Fusion System Zimmer Biomet Spine, Inc. | OVD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2024 | Zimmer Biomet Spine Inc. Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System Open, Classified |
NKB | K150896 |
| Feb 22, 2019 | Zimmer Biomet Spine Inc. Vitality Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use Terminated |
KWQ | K150896 |
| Feb 22, 2019 | Zimmer Biomet Spine Inc. Vitality Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Ort Terminated |
KWP | K171907 |
| Feb 22, 2019 | Zimmer Biomet Spine Inc. Vitality Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Ortho Terminated |
NKB | K150896 K171907 |
| May 15, 2017 | Zimmer Biomet Spine Inc. Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017 Terminated |
LYQ | None listed |
| Mar 16, 2017 | Zimmer Biomet Spine, Inc Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216
The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-th Terminated |
MAX | None listed |
| Jun 30, 2016 | Zimmer Biomet Spine, Inc Zyston Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile. Terminated |
MAX | K153695 |
| Jun 30, 2016 | Zimmer Biomet Spine, Inc Zyston Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile. Terminated |
MAX | K153695 |