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FDA 510(k)

COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES

K-Number: K053189 · 2005-12-09

ApplicantZimmer, Inc.
Decision Date2005-12-09
Product CodeJDC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COONRAD/MORREY TOTAL ELBOW, MODEL 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 2005-12-09 under 510(k) number K053189. 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 8105 SERIES?

COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES is a medical device that received FDA 510(k) clearance on 2005-12-09. The listed applicant is Zimmer, Inc.. The 510(k) number is K053189.

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

COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES received FDA 510(k) clearance on 2005-12-09, under 510(k) number K053189.

Who is the listed applicant for COONRAD/MORREY TOTAL ELBOW, MODEL 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 8105 SERIES?

The FDA product code for COONRAD/MORREY TOTAL ELBOW, MODEL 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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