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FDA 510(k)

Humeris® 135 Shoulder System

K-Number: K222936 · 2022-11-07

ApplicantFx Shoulder USA, Inc.
Decision Date2022-11-07
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Humeris® 135 Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Fx Shoulder USA, Inc.. It received FDA 510(k) clearance on 2022-11-07 under 510(k) number K222936. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Humeris® 135 Shoulder System?

Humeris® 135 Shoulder System is a medical device that received FDA 510(k) clearance on 2022-11-07. The listed applicant is Fx Shoulder USA, Inc.. The 510(k) number is K222936.

When did Humeris® 135 Shoulder System receive FDA 510(k) clearance?

Humeris® 135 Shoulder System received FDA 510(k) clearance on 2022-11-07, under 510(k) number K222936.

Who is the listed applicant for Humeris® 135 Shoulder System?

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

What is the FDA product code for Humeris® 135 Shoulder System?

The FDA product code for Humeris® 135 Shoulder System is PHX.

Other records listing Fx Shoulder USA, 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.

K240278Full Wedge Lateralized and Augmented BaseplatesK223801FX V135(TM) Shoulder ProsthesisK213117FX V135 Shoulder ProsthesisK210790Lateralized and Augmented BaseplatesK201391Easytech® Anatomical Shoulder SystemK191698TiN Coated Humeral Head

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Related Devices (Code: PHX)

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.

K260556Veritas Shoulder SystemRestor3DK261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SAK253992Veritas Reverse Total Shoulder SystemRestor3DK252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

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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