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FDA 510(k)

COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY

K-Number: K071499 · 2007-09-14

ApplicantAesculap Implant Systems, Inc.
Decision Date2007-09-14
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implant Systems, Inc.. It received FDA 510(k) clearance on 2007-09-14 under 510(k) number K071499. 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 TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY?

COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY is a medical device that received FDA 510(k) clearance on 2007-09-14. The listed applicant is Aesculap Implant Systems, Inc.. The 510(k) number is K071499.

When did COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY receive FDA 510(k) clearance?

COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY received FDA 510(k) clearance on 2007-09-14, under 510(k) number K071499.

Who is the listed applicant for COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY?

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

What is the FDA product code for COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY?

The FDA product code for COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY is JWH.

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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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