OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT— 510(k) K890197
Substantially EquivalentOsteonics Corp.
FDA 510(k) clearance K890197 for OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT, Substantially Equivalent on 1989-04-07. Applicant: Osteonics Corp.. Device class: 2.
Clearance details
- Applicant
- Osteonics Corp.
- Product code
- Code KWZ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3310
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Allendale, NJ, US
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More clearances from Osteonics Corp.
view allAdverse events under product code KWZ
product code KWZ- Injury
- 993
- Total
- 993
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.