510(k) K150896 ยท NKB Thoracolumbosacral Pedicle Screw System
Vitality Spinal Fixation System
| Applicant | Zimmer Spine, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Aug 31, 2015 |
| Received | Apr 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150896
| 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 | None listed |
| 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 Intervertebral Body, Appliance, Fixation (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.