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

Name: FDA 510(k) clearance K910083
Creator: U.S. Food and Drug Administration
Published: 1991-04-01

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.. Device class: 2.

Clearance details

Applicant: Osteonics Corp.
Product code: Code HSX
Device class: Class 2
Regulation: 21 CFR 888.3520
Advisory panel: Orthopedic
Date received: 1991-01-08
Decision date: 1991-04-01
Decision: Substantially Equivalent
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 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.