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FDA 510(k)

POROCOAT MARK II TOTAL ELBOW

K-Number: K872084 · 1987-06-25

ApplicantDepuy, Inc.
Decision Date1987-06-25
Product CodeJDC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

POROCOAT MARK II TOTAL ELBOW is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1987-06-25 under 510(k) number K872084. The device is classified under product code JDC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the POROCOAT MARK II TOTAL ELBOW?

POROCOAT MARK II TOTAL ELBOW is a medical device that received FDA 510(k) clearance on 1987-06-25. The listed applicant is Depuy, Inc.. The 510(k) number is K872084.

When did POROCOAT MARK II TOTAL ELBOW receive FDA 510(k) clearance?

POROCOAT MARK II TOTAL ELBOW received FDA 510(k) clearance on 1987-06-25, under 510(k) number K872084.

Who is the listed applicant for POROCOAT MARK II TOTAL ELBOW?

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 MARK II TOTAL ELBOW?

The FDA product code for POROCOAT MARK II TOTAL ELBOW is JDC.

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Other records listing Depuy, Inc. as applicant

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Related Devices (Code: JDC)

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.

K181362TEMA Elbow SystemLima Corporate S.P.A.K181307Zimmer Nexel Total Elbow, Connrad/Morrey Total ElbowZimmer, Inc.K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing CorpK123862ZIMMER NEXEL TOTAL ELBOWZimmer, Inc.K090473DISCOVERY ELBOW - X-SMALLBiomet Manufacturing CorpK060696ACCLAIM TOTAL ELBOW SYSTEMDePuy Orthopaedics, 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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