SyntheCel Dura Repair— 510(k) K212943

Substantially Equivalent

Synthes (USA) Products, LLC

FDA 510(k) clearance K212943 for SyntheCel Dura Repair, Substantially Equivalent on 2022-01-28. Applicant: Synthes (USA) Products, LLC.

Clearance details

Applicant: Synthes (USA) Products, LLC
Product code: Code GXQ
Advisory panel: Neurology
Date received: 2021-09-15
Decision date: 2022-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

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.