FDA 510(k)

INHANCE Shoulder System, Sterile Single Use Instrumentation

K-Number: K231516 · 2023-07-21

Decision Date2023-07-21

Product CodeMBF

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

INHANCE Shoulder System, Sterile Single Use Instrumentation is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2023-07-21 under approval 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. It is manufactured by Depuy Ireland UC. The 510(k) number is K231516.

When was INHANCE Shoulder System, Sterile Single Use Instrumentation approved by the FDA?

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

What company makes INHANCE Shoulder System, Sterile Single Use Instrumentation?

INHANCE Shoulder System, Sterile Single Use Instrumentation is manufactured by Depuy Ireland UC.

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.

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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) PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

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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.