FDA 510(k)

INHANCE INTACT

K-Number: K243248 · 2024-12-23

Decision Date2024-12-23

Product CodePKC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

INHANCE INTACT is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2024-12-23 under approval number K243248. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INHANCE INTACT?

INHANCE INTACT is a medical device that received FDA 510(k) clearance on 2024-12-23. It is manufactured by Depuy Ireland UC. The 510(k) number is K243248.

When was INHANCE INTACT approved by the FDA?

INHANCE INTACT received FDA 510(k) clearance on 2024-12-23, under approval number K243248.

What company makes INHANCE INTACT?

INHANCE INTACT is manufactured by Depuy Ireland UC.

What is the FDA product code for INHANCE INTACT?

The FDA product code for INHANCE INTACT is PKC.

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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.