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FDA 510(k)

TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER

K-Number: K946313 · 1995-03-17

ApplicantSmith and Nephew Donjoy, Inc.
Decision Date1995-03-17
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER is the device name listed in this FDA 510(k) record. The listed applicant is Smith and Nephew Donjoy, Inc.. It received FDA 510(k) clearance on 1995-03-17 under 510(k) number K946313. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER?

TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER is a medical device that received FDA 510(k) clearance on 1995-03-17. The listed applicant is Smith and Nephew Donjoy, Inc.. The 510(k) number is K946313.

When did TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER receive FDA 510(k) clearance?

TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER received FDA 510(k) clearance on 1995-03-17, under 510(k) number K946313.

Who is the listed applicant for TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER?

The FDA 510(k) record lists Smith and Nephew Donjoy, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER?

The FDA product code for TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER is HRX.

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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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