HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT— 510(k) K912395
Substantially Equivalent for Some IndicationsHowmedica Corp.
FDA 510(k) clearance K912395 for HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT, Substantially Equivalent for Some Indications on 1991-07-24. Applicant: Howmedica Corp..
Clearance details
- Applicant
- Howmedica Corp.
- Product code
- Code MEH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Rutherford, NJ, US
Adverse events under product code MEH
product code MEH- Injury
- 2,021
- Total
- 2,021
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.