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FDA 510(k)

Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow

K-Number: K181307 · 2019-01-28

ApplicantZimmer, Inc.
Decision Date2019-01-28
Product CodeJDC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2019-01-28 under 510(k) number K181307. 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 Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow?

Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow is a medical device that received FDA 510(k) clearance on 2019-01-28. The listed applicant is Zimmer, Inc.. The 510(k) number is K181307.

When did Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow receive FDA 510(k) clearance?

Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow received FDA 510(k) clearance on 2019-01-28, under 510(k) number K181307.

Who is the listed applicant for Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow?

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 Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow?

The FDA product code for Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow is JDC.

Related Clinical Trials

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.

NCT02469662Clinical Outcomes Study of the Nexel Total ElbowRECRUITING

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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.K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp

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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