K854943Substantially Equivalent for Some Indications

Omknee System, Porous Coated

Name: K854943 Omknee System, Porous Coated
Creator: Orthomet, Inc.
Published: 1986-02-20
License: https://open.fda.gov/license/

Orthomet, Inc., Plymouth MN / Traditional, Substantially Equivalent for Some Indications

FDA source

K854943 is the FDA 510(k) clearance record for OMKNEE SYSTEM, POROUS COATED, cleared for Orthomet, Inc. on 1986-02-20. FDA records list 60 510(k) clearances for Orthomet, Inc., from 1986-02-18 to 1995-06-07. As of 2026-09-10, FDA records show no recalls naming K854943.

Clearance record

Decision date: 1986-02-20
Received: 1985-12-10 (72 days to decision)
Review panel: Unknown
Applicant: Orthomet, Inc. 4230 Trenton Ln., Plymouth MN
Third party review: No