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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 the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2023-09-26 under 510(k) 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. The listed applicant is Arthrex, Inc.. The 510(k) number is K230513.

When did Arthrex Univers Apex OptiFit Humeral Stem receive FDA 510(k) clearance?

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

Who is the listed applicant for Arthrex Univers Apex OptiFit Humeral Stem?

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

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.

Other records listing Arthrex, Inc. as applicant

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Related Devices (Code: KWS)

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.

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, 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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