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FDA 510(k)

DISCOVERY ELBOW - X-SMALL

K-Number: K090473 · 2009-03-25

ApplicantBiomet Manufacturing Corp
Decision Date2009-03-25
Product CodeJDC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DISCOVERY ELBOW - X-SMALL is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2009-03-25 under 510(k) number K090473. 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 DISCOVERY ELBOW - X-SMALL?

DISCOVERY ELBOW - X-SMALL is a medical device that received FDA 510(k) clearance on 2009-03-25. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K090473.

When did DISCOVERY ELBOW - X-SMALL receive FDA 510(k) clearance?

DISCOVERY ELBOW - X-SMALL received FDA 510(k) clearance on 2009-03-25, under 510(k) number K090473.

Who is the listed applicant for DISCOVERY ELBOW - X-SMALL?

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

What is the FDA product code for DISCOVERY ELBOW - X-SMALL?

The FDA product code for DISCOVERY ELBOW - X-SMALL 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.K060696ACCLAIM TOTAL ELBOW SYSTEMDePuy Orthopaedics, Inc.K053189COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIESZimmer, 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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