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FDA 510(k)

POROCOAT SYNATOMIC UNICONDYLAR KNEE

K-Number: K853020 · 1985-11-25

ApplicantDepuy, Inc.
Decision Date1985-11-25
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

POROCOAT SYNATOMIC UNICONDYLAR KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1985-11-25 under 510(k) number K853020. 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 POROCOAT SYNATOMIC UNICONDYLAR KNEE?

POROCOAT SYNATOMIC UNICONDYLAR KNEE is a medical device that received FDA 510(k) clearance on 1985-11-25. The listed applicant is Depuy, Inc.. The 510(k) number is K853020.

When did POROCOAT SYNATOMIC UNICONDYLAR KNEE receive FDA 510(k) clearance?

POROCOAT SYNATOMIC UNICONDYLAR KNEE received FDA 510(k) clearance on 1985-11-25, under 510(k) number K853020.

Who is the listed applicant for POROCOAT SYNATOMIC UNICONDYLAR KNEE?

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

What is the FDA product code for POROCOAT SYNATOMIC UNICONDYLAR KNEE?

The FDA product code for POROCOAT SYNATOMIC UNICONDYLAR KNEE is HSX.

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Other records listing Depuy, Inc. 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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