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FDA 510(k)

INTRAFIX TIBIAL SHEATH

K-Number: K102443 · 2010-10-20

ApplicantDepuy Mitek, A Johnson & Johnson Company
Decision Date2010-10-20
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTRAFIX TIBIAL SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. It received FDA 510(k) clearance on 2010-10-20 under 510(k) number K102443. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAFIX TIBIAL SHEATH?

INTRAFIX TIBIAL SHEATH is a medical device that received FDA 510(k) clearance on 2010-10-20. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. The 510(k) number is K102443.

When did INTRAFIX TIBIAL SHEATH receive FDA 510(k) clearance?

INTRAFIX TIBIAL SHEATH received FDA 510(k) clearance on 2010-10-20, under 510(k) number K102443.

Who is the listed applicant for INTRAFIX TIBIAL SHEATH?

The FDA 510(k) record lists Depuy Mitek, A Johnson & Johnson Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRAFIX TIBIAL SHEATH?

The FDA product code for INTRAFIX TIBIAL SHEATH is MBI.

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Related Devices (Code: MBI)

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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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