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FDA 510(k)

INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid

K-Number: K230831 · 2023-11-13

ApplicantDepuy Ireland UC
Decision Date2023-11-13
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2023-11-13 under approval number K230831. 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 Convertible Glenoid Inserts, INHANCE Convertible Glenoid?

INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid is a medical device that received FDA 510(k) clearance on 2023-11-13. It is manufactured by Depuy Ireland UC. The 510(k) number is K230831.

When was INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid approved by the FDA?

INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid received FDA 510(k) clearance on 2023-11-13, under approval number K230831.

What company makes INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid?

INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid is manufactured by Depuy Ireland UC.

What is the FDA product code for INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid?

The FDA product code for INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid is MBF.

Related Clinical Trials

NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT06323980 INHANCE Stemless Reverse Shoulder IDE RECRUITING NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING NCT07550543 PEMF Therapy in Shoulder Tendinopathy RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

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Related Devices (Code: MBF)

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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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