510(k) K150552 ยท NKG Posterior Cervical Screw System
ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS
| Applicant | Globus Medical, Inc., Audubon PA, US |
| Decision | Substantially Equivalent, Jun 4, 2015 |
| Received | Mar 4, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150552
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2017 | Zimmer Biomet, Inc. G7 DUAL MOBILITY LINER 44MM F
Product Usage:
Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The resu Terminated |
KWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.