510(k) K151224 ยท NKG Posterior Cervical Screw System
Lineum OCT Spine System
| Applicant | Biomet Spine, Broomfield CO, US |
| Decision | Substantially Equivalent, Jun 30, 2015 |
| Received | May 7, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151224
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2018 | Zimmer Biomet, Inc. Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728
The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute an Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.