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FDA 510(k)

INHANCE INTACT™

K-Number: K243248 · 2024-12-23

ApplicantDepuy Ireland UC
Decision Date2024-12-23
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INHANCE INTACT™ 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 2024-12-23 under 510(k) 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. The listed applicant is Depuy Ireland UC. The 510(k) number is K243248.

When did INHANCE INTACT™ receive FDA 510(k) clearance?

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

Who is the listed applicant for INHANCE INTACT™?

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 INTACT™?

The FDA product code for INHANCE INTACT™ is PKC.

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Related Devices (Code: 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.

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