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FDA 510(k)

Comprehensive SRS/Nexel Elbow

K-Number: K153398 · 2016-02-03

ApplicantBiomet Manufacturing Corp
Decision Date2016-02-03
Product CodeJDC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Comprehensive SRS/Nexel Elbow 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 2016-02-03 under 510(k) number K153398. 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 Comprehensive SRS/Nexel Elbow?

Comprehensive SRS/Nexel Elbow is a medical device that received FDA 510(k) clearance on 2016-02-03. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K153398.

When did Comprehensive SRS/Nexel Elbow receive FDA 510(k) clearance?

Comprehensive SRS/Nexel Elbow received FDA 510(k) clearance on 2016-02-03, under 510(k) number K153398.

Who is the listed applicant for Comprehensive SRS/Nexel Elbow?

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 Comprehensive SRS/Nexel Elbow?

The FDA product code for Comprehensive SRS/Nexel Elbow is JDC.

Other records listing Biomet Manufacturing Corp 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.

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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