OSTEONICS SHOULDER HUMERAL COMPONENTS— 510(k) K955731
Substantially Equivalent for Some IndicationsOsteonics Corp.
FDA 510(k) clearance K955731 for OSTEONICS SHOULDER HUMERAL COMPONENTS, Substantially Equivalent for Some Indications on 1996-03-05. Applicant: Osteonics Corp..
Clearance details
- Applicant
- Osteonics Corp.
- Product code
- Code KWS
- 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 KWS
product code KWS- Death
- 6
- Injury
- 9,652
- Malfunction
- 1,385
- Other
- 1
- Total
- 11,044
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.