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FDA 510(k)

INHANCETM Shoulder System – Humeral Stems and Stemless

K-Number: K223211 · 2022-12-02

ApplicantDepuy Ireland UC
Decision Date2022-12-02
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INHANCETM Shoulder System – Humeral Stems and Stemless is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2022-12-02 under 510(k) number K223211. 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 INHANCETM Shoulder System – Humeral Stems and Stemless?

INHANCETM Shoulder System – Humeral Stems and Stemless is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is Depuy Ireland UC. The 510(k) number is K223211.

When did INHANCETM Shoulder System – Humeral Stems and Stemless receive FDA 510(k) clearance?

INHANCETM Shoulder System – Humeral Stems and Stemless received FDA 510(k) clearance on 2022-12-02, under 510(k) number K223211.

Who is the listed applicant for INHANCETM Shoulder System – Humeral Stems and Stemless?

The FDA 510(k) record lists Depuy Ireland UC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INHANCETM Shoulder System – Humeral Stems and Stemless?

The FDA product code for INHANCETM Shoulder System – Humeral Stems and Stemless is PHX.

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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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