SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT— 510(k) K053199
Substantially EquivalentSynthes (Usa)
FDA 510(k) clearance K053199 for SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT, Substantially Equivalent on 2005-12-14. Applicant: Synthes (Usa). Device class: 2.
Clearance details
- Applicant
- Synthes (Usa)
- Product code
- Code GXN
- Device class
- Class 2
- Regulation
- 21 CFR 882.5330
- Advisory panel
- Neurology
- Date received
- Decision date
- 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, 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.