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FDA 510(k)

COLUMBUS REVISION KNEE SYSTEM

K-Number: K122985 · 2012-10-26

ApplicantAesculap Implant System, Inc.
Decision Date2012-10-26
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COLUMBUS REVISION KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implant System, Inc.. It received FDA 510(k) clearance on 2012-10-26 under 510(k) number K122985. 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 REVISION KNEE SYSTEM?

COLUMBUS REVISION KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-10-26. The listed applicant is Aesculap Implant System, Inc.. The 510(k) number is K122985.

When did COLUMBUS REVISION KNEE SYSTEM receive FDA 510(k) clearance?

COLUMBUS REVISION KNEE SYSTEM received FDA 510(k) clearance on 2012-10-26, under 510(k) number K122985.

Who is the listed applicant for COLUMBUS REVISION KNEE SYSTEM?

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

What is the FDA product code for COLUMBUS REVISION KNEE SYSTEM?

The FDA product code for COLUMBUS REVISION KNEE SYSTEM is JWH.

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Other records listing Aesculap Implant System, Inc. as applicant

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Related Devices (Code: 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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