510(k) K171907 · NKB Thoracolumbosacral Pedicle Screw System
Vitality® Spinal Fixation System
| Applicant | Zimmer Biomet Spine, Inc., Westminister CO, US |
| Decision | Substantially Equivalent, Jul 14, 2017 |
| Received | Jun 26, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K171907
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.