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FDA 510(k)

COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE

K-Number: K053579 · 2006-05-17

ApplicantAesculap, Inc.
Decision Date2006-05-17
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2006-05-17 under 510(k) number K053579. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE?

COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE is a medical device that received FDA 510(k) clearance on 2006-05-17. The listed applicant is Aesculap, Inc.. The 510(k) number is K053579.

When did COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE receive FDA 510(k) clearance?

COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE received FDA 510(k) clearance on 2006-05-17, under 510(k) number K053579.

Who is the listed applicant for COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE?

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

What is the FDA product code for COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE?

The FDA product code for COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE is JWH.

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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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