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FDA 510(k)

CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT)

K-Number: K063432 · 2007-03-16

ApplicantConformis, Inc.
Decision Date2007-03-16
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT) is the device name listed in this FDA 510(k) record. The listed applicant is Conformis, Inc.. It received FDA 510(k) clearance on 2007-03-16 under 510(k) number K063432. 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 CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT)?

CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT) is a medical device that received FDA 510(k) clearance on 2007-03-16. The listed applicant is Conformis, Inc.. The 510(k) number is K063432.

When did CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT) receive FDA 510(k) clearance?

CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT) received FDA 510(k) clearance on 2007-03-16, under 510(k) number K063432.

Who is the listed applicant for CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT)?

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

What is the FDA product code for CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT)?

The FDA product code for CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT) is HSX.

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Related Devices (Code: 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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