510(k) K131792 ยท GXQ Dura Substitute
SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY
| Applicant | Synthes, Inc., West Chester PA, US |
| Decision | Substantially Equivalent, Dec 16, 2013 |
| Received | Jun 18, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131792
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 8, 2015 | Synthes (USA) Products LLC SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute
Device listing number: D140596, D211012
SYNTHECEL Dura Repair is intended for use as a dura replacement f Terminated |
GXQ | None listed |
| Dec 8, 2015 | Synthes (USA) Products LLC SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute
Device listing number: D140596, D211012
SYNTHECEL Dura Repair is intended for use as a dura replacement f Terminated |
GXQ | None listed |
| Dec 8, 2015 | Synthes (USA) Products LLC SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute
Device listing number: D140596, D211012
SYNTHECEL Dura Repair is intended for use as a dura replacement f Terminated |
GXQ | None listed |
| Dec 8, 2015 | Synthes (USA) Products LLC SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute
Device listing number: D140596, D211012
SYNTHECEL Dura Repair is intended for use as a dura replacement f Terminated |
GXQ | None listed |
| Dec 8, 2015 | Synthes (USA) Products LLC SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute
Device listing number: D140596, D211012
SYNTHECEL Dura Repair is intended for use as a dura replacement f Terminated |
GXQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.