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FDA 510(k)

UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS

K-Number: K050373 · 2005-10-11

ApplicantArthrosurface, Inc.
Decision Date2005-10-11
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Arthrosurface, Inc.. It received FDA 510(k) clearance on 2005-10-11 under 510(k) number K050373. 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 UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS?

UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS is a medical device that received FDA 510(k) clearance on 2005-10-11. The listed applicant is Arthrosurface, Inc.. The 510(k) number is K050373.

When did UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS receive FDA 510(k) clearance?

UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS received FDA 510(k) clearance on 2005-10-11, under 510(k) number K050373.

Who is the listed applicant for UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS?

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

What is the FDA product code for UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS?

The FDA product code for UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS is HSX.

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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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