510(k) K111176 ยท GWO Plate, Cranioplasty, Preformed, Alterable
OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM
| Applicant | Osteomed LP, Addison TX, US |
| Decision | Substantially Equivalent, Aug 15, 2011 |
| Received | Apr 27, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111176
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2023 | Osteomed, LLC REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile Open, Classified |
GWO | None listed |
| Jul 7, 2023 | Osteomed, LLC REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile Open, Classified |
GWO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.