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FDA 510(k)

Arthrex Univers Apex OptiFit Humeral Stem

K-Number: K230513 · 2023-09-26

ApplicantArthrex, Inc.
Decision Date2023-09-26
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Univers Apex OptiFit Humeral Stem is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2023-09-26 under approval number K230513. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Univers Apex OptiFit Humeral Stem?

Arthrex Univers Apex OptiFit Humeral Stem is a medical device that received FDA 510(k) clearance on 2023-09-26. It is manufactured by Arthrex, Inc.. The 510(k) number is K230513.

When was Arthrex Univers Apex OptiFit Humeral Stem approved by the FDA?

Arthrex Univers Apex OptiFit Humeral Stem received FDA 510(k) clearance on 2023-09-26, under approval number K230513.

What company makes Arthrex Univers Apex OptiFit Humeral Stem?

Arthrex Univers Apex OptiFit Humeral Stem is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Univers Apex OptiFit Humeral Stem?

The FDA product code for Arthrex Univers Apex OptiFit Humeral Stem is KWS.

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Related Devices (Code: KWS)

K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S. K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)Stryker GmbH K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. K161108Arthrex VaultLock GlenoidArthrex, Inc. K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc. K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.

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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