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FDA 510(k)

SINGLE AXLE TOTAL ELBOW

K-Number: K983036 · 1999-04-30

ApplicantBiomet, Inc.
Decision Date1999-04-30
Product CodeJDC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SINGLE AXLE TOTAL ELBOW is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1999-04-30 under 510(k) number K983036. 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 SINGLE AXLE TOTAL ELBOW?

SINGLE AXLE TOTAL ELBOW is a medical device that received FDA 510(k) clearance on 1999-04-30. The listed applicant is Biomet, Inc.. The 510(k) number is K983036.

When did SINGLE AXLE TOTAL ELBOW receive FDA 510(k) clearance?

SINGLE AXLE TOTAL ELBOW received FDA 510(k) clearance on 1999-04-30, under 510(k) number K983036.

Who is the listed applicant for SINGLE AXLE TOTAL ELBOW?

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

What is the FDA product code for SINGLE AXLE TOTAL ELBOW?

The FDA product code for SINGLE AXLE TOTAL ELBOW is JDC.

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Other records listing Biomet, 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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