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FDA 510(k)

OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM

K-Number: K862837 · 1986-12-22

ApplicantOsteonics Corp.
Decision Date1986-12-22
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1986-12-22 under 510(k) number K862837. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM?

OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM is a medical device that received FDA 510(k) clearance on 1986-12-22. The listed applicant is Osteonics Corp.. The 510(k) number is K862837.

When did OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM receive FDA 510(k) clearance?

OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM received FDA 510(k) clearance on 1986-12-22, under 510(k) number K862837.

Who is the listed applicant for OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM?

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

What is the FDA product code for OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM?

The FDA product code for OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM is HSX.

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Other records listing Osteonics Corp. as applicant

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Related Devices (Code: HSX)

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.

K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus OrthopedicsK251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.K251834Persona Partial KneeZimmer BiometK251618MOTO Partial Knee System ExtensionMedacta International S.A.K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.

Official Source

View on FDA Database →

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

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