OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES— 510(k) K874635

Name: FDA 510(k) clearance K874635
Creator: U.S. Food and Drug Administration
Published: 1988-03-10

Substantially Equivalent for Some Indications

Osteonics 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.. Device class: 2.

Clearance details

Applicant: Osteonics Corp.
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 1987-11-10
Decision date: 1988-03-10
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

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K982798 — OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM1999-03-25
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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, 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.