SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY— 510(k) K131792
Substantially EquivalentSynthes, Inc.
FDA 510(k) clearance K131792 for SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY, Substantially Equivalent on 2013-12-16. Applicant: Synthes, Inc.. Device class: 2.
Clearance details
- Applicant
- Synthes, Inc.
- Product code
- Code GXQ
- Device class
- Class 2
- Regulation
- 21 CFR 882.5910
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
Recent devices under product code GXQ
view allMore clearances from Synthes, Inc.
view allAdverse events under product code GXQ
product code GXQ- Death
- 11
- Injury
- 446
- Other
- 1
- Total
- 458
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K131792
K-number listed on FDA's recall record- Z-1383-2016 — 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 for the repair of dura mater in adults.
- Z-1384-2016 — 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 for the repair of dura mater in adults.
- Z-1385-2016 — 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 for the repair of dura mater in adults.
- Z-1386-2016 — 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 for the repair of dura mater in adults.
- Z-1387-2016 — 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 for the repair of dura mater in adults.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131792.
Data sourced from openFDA. This site is unofficial and independent of the FDA.