SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY— 510(k) K131792

Substantially Equivalent

Synthes, Inc.

FDA 510(k) clearance K131792 for SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY, Substantially Equivalent on 2013-12-16. Applicant: Synthes, Inc..

Clearance details

Applicant: Synthes, Inc.
Product code: Code GXQ
Advisory panel: Neurology
Date received: 2013-06-18
Decision date: 2013-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

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Adverse events under product code GXQ

product code GXQ

Death: 11
Injury: 446
Other: 1
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.