510(k) K082650 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, Nov 18, 2008 |
| Received | Sep 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082650
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2015 | Synthes (USA) Products LLC Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forea Terminated |
KTT | None listed |
| Jun 19, 2014 | Synthes, Inc. Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components. Terminated |
KTT | None listed |
| Jul 29, 2013 | Synthes USA HQ, Inc. Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599
Synthes Large External Fixation is intended for use to provide treatment for long bone and Open, Classified |
KTT | None listed |
| Mar 11, 2013 | Synthes USA HQ, Inc. Large Combination Clamp/Large External Fixation System, Part Number 390.005
Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures Terminated |
KTT | None listed |
| Nov 13, 2012 | Synthes USA HQ, Inc. Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007.
Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the co Terminated |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.