510(k) K031807 ยท DZL Screw, Fixation, Intraosseous
SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Jul 2, 2003 |
| Received | Jun 11, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031807
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 5, 2016 | Synthes (USA) Products LLC Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E
Product Usage:
The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and cr Terminated |
DZL | None listed |
| Apr 5, 2016 | Synthes (USA) Products LLC Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E
Product Usage:
The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and cr Terminated |
DZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.