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FDA 510(k)

UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD

K-Number: K043570 · 2005-03-14

ApplicantConformis, Inc.
Decision Date2005-03-14
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD is the device name listed in this FDA 510(k) record. The listed applicant is Conformis, Inc.. It received FDA 510(k) clearance on 2005-03-14 under 510(k) number K043570. 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 UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD?

UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD is a medical device that received FDA 510(k) clearance on 2005-03-14. The listed applicant is Conformis, Inc.. The 510(k) number is K043570.

When did UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD receive FDA 510(k) clearance?

UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD received FDA 510(k) clearance on 2005-03-14, under 510(k) number K043570.

Who is the listed applicant for UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD?

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 UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD?

The FDA product code for UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD is HSX.

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Related Devices (Code: HSX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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