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FDA 510(k)

JOURNEY UNICONDYLAR FEMORAL IMPLANT

K-Number: K073175 · 2007-12-20

ApplicantSmith & Nephew, Inc.
Decision Date2007-12-20
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JOURNEY UNICONDYLAR FEMORAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2007-12-20 under 510(k) number K073175. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JOURNEY UNICONDYLAR FEMORAL IMPLANT?

JOURNEY UNICONDYLAR FEMORAL IMPLANT is a medical device that received FDA 510(k) clearance on 2007-12-20. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K073175.

When did JOURNEY UNICONDYLAR FEMORAL IMPLANT receive FDA 510(k) clearance?

JOURNEY UNICONDYLAR FEMORAL IMPLANT received FDA 510(k) clearance on 2007-12-20, under 510(k) number K073175.

Who is the listed applicant for JOURNEY UNICONDYLAR FEMORAL IMPLANT?

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

What is the FDA product code for JOURNEY UNICONDYLAR FEMORAL IMPLANT?

The FDA product code for JOURNEY UNICONDYLAR FEMORAL IMPLANT is HSX.

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Other records listing Smith & Nephew, Inc. as applicant

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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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