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FDA 510(k)

INHANCE™ Shoulder System, Sterile Single Use Instrumentation

K-Number: K231516 · 2023-07-21

ApplicantDepuy Ireland UC
Decision Date2023-07-21
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INHANCE™ Shoulder System, Sterile Single Use Instrumentation 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 2023-07-21 under 510(k) number K231516. 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 INHANCE™ Shoulder System, Sterile Single Use Instrumentation?

INHANCE™ Shoulder System, Sterile Single Use Instrumentation is a medical device that received FDA 510(k) clearance on 2023-07-21. The listed applicant is Depuy Ireland UC. The 510(k) number is K231516.

When did INHANCE™ Shoulder System, Sterile Single Use Instrumentation receive FDA 510(k) clearance?

INHANCE™ Shoulder System, Sterile Single Use Instrumentation received FDA 510(k) clearance on 2023-07-21, under 510(k) number K231516.

Who is the listed applicant for INHANCE™ Shoulder System, Sterile Single Use Instrumentation?

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 INHANCE™ Shoulder System, Sterile Single Use Instrumentation?

The FDA product code for INHANCE™ Shoulder System, Sterile Single Use Instrumentation is MBF.

Other records listing Depuy Ireland UC as applicant

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Related Devices (Code: MBF)

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.

K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)Zimmer, Inc.K251098Identity Revision Humeral StemsZimmer, Inc.K250848Identity Shoulder SystemZimmer, Inc.K240876Identity Shoulder SystemZimmer, Inc.K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.

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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