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FDA 510(k)

OMKNEE SYSTEM, POROUS COATED

K-Number: K854943 · 1986-02-20

ApplicantOrthomet, Inc.
Decision Date1986-02-20
Product Code
DecisionSubstantially Equivalent for Some Indications

Device Summary

OMKNEE SYSTEM, POROUS COATED is the device name listed in this FDA 510(k) record. The listed applicant is Orthomet, Inc.. It received FDA 510(k) clearance on 1986-02-20 under 510(k) number K854943. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OMKNEE SYSTEM, POROUS COATED?

OMKNEE SYSTEM, POROUS COATED is a medical device that received FDA 510(k) clearance on 1986-02-20. The listed applicant is Orthomet, Inc.. The 510(k) number is K854943.

When did OMKNEE SYSTEM, POROUS COATED receive FDA 510(k) clearance?

OMKNEE SYSTEM, POROUS COATED received FDA 510(k) clearance on 1986-02-20, under 510(k) number K854943.

Who is the listed applicant for OMKNEE SYSTEM, POROUS COATED?

The FDA 510(k) record lists Orthomet, Inc. as the applicant. This does not by itself establish the device manufacturer.

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Other records listing Orthomet, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K936310ORTHOMET HMC FEMORAL STEM COMPONENTK945783ORTHOMET TITANIUM HYBRID FEMORAL STEMK943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYK944752ORTHOMET RESURFACING FEMORAL COMPONENTK930771PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEMK926334AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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