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FDA 510(k)

Identity Revision Humeral Stems

K-Number: K251098 · 2025-08-11

ApplicantZimmer, Inc.
Decision Date2025-08-11
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Identity Revision Humeral Stems is a medical device manufactured by Zimmer, Inc.. It received FDA 510(k) clearance on 2025-08-11 under approval number K251098. 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 Revision Humeral Stems?

Identity Revision Humeral Stems is a medical device that received FDA 510(k) clearance on 2025-08-11. It is manufactured by Zimmer, Inc.. The 510(k) number is K251098.

When was Identity Revision Humeral Stems approved by the FDA?

Identity Revision Humeral Stems received FDA 510(k) clearance on 2025-08-11, under approval number K251098.

What company makes Identity Revision Humeral Stems?

Identity Revision Humeral Stems is manufactured by Zimmer, Inc..

What is the FDA product code for Identity Revision Humeral Stems?

The FDA product code for Identity Revision Humeral Stems is MBF.

Related Clinical Trials

NCT06788717 MDR - Comprehensive Primary Revision Stems PMCF 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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