SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT— 510(k) K053199

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K053199 for SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT, Substantially Equivalent on 2005-12-14. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code GXN
Advisory panel: Neurology
Date received: 2005-11-16
Decision date: 2005-12-14
Decision: Substantially Equivalent
Clearance type: Special
Location: West Chester, PA, US

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Adverse events under product code GXN

product code GXN

Injury: 208
Total: 208

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.