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FDA 510(k)

Identity Shoulder System

K-Number: K250848 · 2025-07-02

ApplicantZimmer, Inc.
Decision Date2025-07-02
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Identity Shoulder System is a medical device manufactured by Zimmer, Inc.. It received FDA 510(k) clearance on 2025-07-02 under approval number K250848. 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 2025-07-02. It is manufactured by Zimmer, Inc.. The 510(k) number is K250848.

When was Identity Shoulder System approved by the FDA?

Identity Shoulder System received FDA 510(k) clearance on 2025-07-02, under approval number K250848.

What company makes Identity Shoulder System?

Identity Shoulder System is manufactured by Zimmer, Inc..

What is the FDA product code for Identity Shoulder System?

The FDA product code for Identity Shoulder System is MBF.

Related Clinical Trials

NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING NCT07550543 PEMF Therapy in Shoulder Tendinopathy RECRUITING NCT07421245 OsseoFit Stemless Shoulder System (Anatomic) NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by Zimmer, Inc.

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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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