OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT— 510(k) K973406
Substantially Equivalent for Some IndicationsOsteonics Corp.
FDA 510(k) clearance K973406 for OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT, Substantially Equivalent for Some Indications on 1997-12-08. Applicant: Osteonics Corp..
Clearance details
- Applicant
- Osteonics Corp.
- Product code
- Code JWH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Allendale, NJ, US
Adverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
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.