OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM— 510(k) K862837

Name: FDA 510(k) clearance K862837
Creator: U.S. Food and Drug Administration
Published: 1986-12-22

Substantially Equivalent for Some Indications

Osteonics Corp.

FDA 510(k) clearance K862837 for OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM, Substantially Equivalent for Some Indications on 1986-12-22. 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: 1986-07-25
Decision date: 1986-12-22
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Osteonics Corp.

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K983657 — OSTEONICS SERIES 7000 AD TIBIAL TRAY2000-04-06
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K984375 — OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY1999-04-30
K982798 — OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM1999-03-25
K984585 — OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE1999-02-24

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.