INHANCE Reverse Shoulder System
K-Number: K253624 · 2026-03-11
ApplicantDepuy Ireland UC
Decision Date2026-03-11
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
INHANCE Reverse Shoulder System is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2026-03-11 under approval number K253624. 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 INHANCE Reverse Shoulder System?
INHANCE Reverse Shoulder System is a medical device that received FDA 510(k) clearance on 2026-03-11. It is manufactured by Depuy Ireland UC. The 510(k) number is K253624.
When was INHANCE Reverse Shoulder System approved by the FDA?
INHANCE Reverse Shoulder System received FDA 510(k) clearance on 2026-03-11, under approval number K253624.
What company makes INHANCE Reverse Shoulder System?
INHANCE Reverse Shoulder System is manufactured by Depuy Ireland UC.
What is the FDA product code for INHANCE Reverse Shoulder System?
The FDA product code for INHANCE Reverse Shoulder System is PHX.
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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.