510(k) K113071 ยท GXQ Dura Substitute
SYNTHECEL DURA REPLACEMENT DEVICES
| Applicant | Synthes, West Chester PA, US |
| Decision | Substantially Equivalent, Jan 9, 2012 |
| Received | Oct 17, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113071
| 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.