SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS— 510(k) K963192
Substantially Equivalent for Some IndicationsSynthes (Usa)
FDA 510(k) clearance K963192 for SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS, Substantially Equivalent for Some Indications on 1996-11-08. Applicant: Synthes (Usa).
Clearance details
- Applicant
- Synthes (Usa)
- Product code
- Code HWC
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Paoli, PA, US
Adverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
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.