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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 the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2016-11-01 under 510(k) 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. The listed applicant is Zimmer GmbH. The 510(k) number is K161620.

When did Anatomical Shoulder Domelock Dome centric receive FDA 510(k) clearance?

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

Who is the listed applicant for Anatomical Shoulder Domelock Dome centric?

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

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

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.

NCT03312465Anatomical Shoulder Domelock System StudyACTIVE_NOT_RECRUITING

Other records listing Zimmer GmbH as applicant

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.

PMA P060037Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearingK261683Augment Off-Axis Instrument SystemK260831Z1 Hip SystemK251840Zimmer® Persona® Personalized Knee SystemK260182Avenir® Müller Stem; Avenir Complete™ Hip SystemK253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

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Related Devices (Code: HSD)

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.

K233260Univers Revers CA Head and AdapterArthrex, Inc.K221232Univers Revers Humeral Cup ImplantArthrex, Inc.K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbHK193122Biocore9 Humeral Resurfacing SystemBiocore9, LLCK173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, 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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