OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES— 510(k) K874635
Substantially Equivalent for Some IndicationsOsteonics Corp.
FDA 510(k) clearance K874635 for OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES, Substantially Equivalent for Some Indications on 1988-03-10. 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.