OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES— 510(k) K910083

Substantially Equivalent

Osteonics Corp.

FDA 510(k) clearance K910083 for OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES, Substantially Equivalent on 1991-04-01. Applicant: Osteonics Corp..

Clearance details

Applicant: Osteonics Corp.
Product code: Code HSX
Advisory panel: Orthopedic
Date received: 1991-01-08
Decision date: 1991-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

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Adverse events under product code HSX

product code HSX

Injury: 1,003
Other: 1
Total: 1,004

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.