510(k) K051600 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, Jul 27, 2005 |
| Received | Jun 16, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051600
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2009 | Synthes Spine Square Nut MR Safe, Catalog Number 03.311.060.
The Square Nut MR Safe is used in conjunction with Synthes Distraction Osteogenesis Ring Systems. It can be used to secure components together or as a Terminated |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.