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FDA 510(k)

Anatomical Shoulder Domelock Dome centric

K-Number: K161620 · 2016-11-01

ApplicantZimmer GmbH
Decision Date2016-11-01
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Anatomical Shoulder Domelock Dome centric is a medical device manufactured by Zimmer GmbH. It received FDA 510(k) clearance on 2016-11-01 under approval number K161620. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anatomical Shoulder Domelock Dome centric?

Anatomical Shoulder Domelock Dome centric is a medical device that received FDA 510(k) clearance on 2016-11-01. It is manufactured by Zimmer GmbH. The 510(k) number is K161620.

When was Anatomical Shoulder Domelock Dome centric approved by the FDA?

Anatomical Shoulder Domelock Dome centric received FDA 510(k) clearance on 2016-11-01, under approval number K161620.

What company makes Anatomical Shoulder Domelock Dome centric?

Anatomical Shoulder Domelock Dome centric is manufactured by Zimmer GmbH.

What is the FDA product code for Anatomical Shoulder Domelock Dome centric?

The FDA product code for Anatomical Shoulder Domelock Dome centric is HSD.

Related Clinical Trials

NCT03312465 Anatomical Shoulder Domelock System Study ACTIVE_NOT_RECRUITING

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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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