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FDA 510(k)

COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES

K-Number: K001989 · 2000-07-25

ApplicantZimmer, Inc.
Decision Date2000-07-25
Product CodeJDC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2000-07-25 under 510(k) number K001989. The device is classified under product code JDC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES?

COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES is a medical device that received FDA 510(k) clearance on 2000-07-25. The listed applicant is Zimmer, Inc.. The 510(k) number is K001989.

When did COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES receive FDA 510(k) clearance?

COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES received FDA 510(k) clearance on 2000-07-25, under 510(k) number K001989.

Who is the listed applicant for COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES?

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

What is the FDA product code for COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES?

The FDA product code for COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES is JDC.

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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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