FDA 510(k)

Identity Shoulder System

K-Number: K240876 · 2024-06-12

Decision Date2024-06-12

Product CodeMBF

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Identity Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2024-06-12 under 510(k) number K240876. The device is classified under product code MBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Identity Shoulder System?

Identity Shoulder System is a medical device that received FDA 510(k) clearance on 2024-06-12. The listed applicant is Zimmer, Inc.. The 510(k) number is K240876.

When did Identity Shoulder System receive FDA 510(k) clearance?

Identity Shoulder System received FDA 510(k) clearance on 2024-06-12, under 510(k) number K240876.

Who is the listed applicant for Identity Shoulder System?

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 Identity Shoulder System?

The FDA product code for Identity Shoulder System is MBF.

Other records listing Zimmer, Inc. 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 bearing K261683Augment Off-Axis Instrument System K260831Z1 Hip System K251840Zimmer® Persona® Personalized Knee System K260182Avenir® Müller Stem; Avenir Complete™ Hip System K253592Zimmer 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: MBF)

K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)Zimmer, Inc.K251098Identity Revision Humeral StemsZimmer, Inc.K250848Identity Shoulder SystemZimmer, Inc.K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.