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FDA 510(k)

Sidus Stem-Free Shoulder

K-Number: K171858 · 2017-12-18

ApplicantZimmer GmbH
Decision Date2017-12-18
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Sidus Stem-Free Shoulder is a medical device manufactured by Zimmer GmbH. It received FDA 510(k) clearance on 2017-12-18 under approval number K171858. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sidus Stem-Free Shoulder?

Sidus Stem-Free Shoulder is a medical device that received FDA 510(k) clearance on 2017-12-18. It is manufactured by Zimmer GmbH. The 510(k) number is K171858.

When was Sidus Stem-Free Shoulder approved by the FDA?

Sidus Stem-Free Shoulder received FDA 510(k) clearance on 2017-12-18, under approval number K171858.

What company makes Sidus Stem-Free Shoulder?

Sidus Stem-Free Shoulder is manufactured by Zimmer GmbH.

What is the FDA product code for Sidus Stem-Free Shoulder?

The FDA product code for Sidus Stem-Free Shoulder is PKC.

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Related Devices (Code: PKC)

K173388Exactech Equinoxe Stemless ShoulderExactech, Inc. K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc. K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P. K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, 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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