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FDA 510(k)

CONFORMIS UNI-CONDYLAR KNEE SYSTEM

K-Number: K072586 · 2007-11-08

ApplicantConformis, Inc.
Decision Date2007-11-08
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONFORMIS UNI-CONDYLAR KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Conformis, Inc.. It received FDA 510(k) clearance on 2007-11-08 under 510(k) number K072586. 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 UNI-CONDYLAR KNEE SYSTEM?

CONFORMIS UNI-CONDYLAR KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2007-11-08. The listed applicant is Conformis, Inc.. The 510(k) number is K072586.

When did CONFORMIS UNI-CONDYLAR KNEE SYSTEM receive FDA 510(k) clearance?

CONFORMIS UNI-CONDYLAR KNEE SYSTEM received FDA 510(k) clearance on 2007-11-08, under 510(k) number K072586.

Who is the listed applicant for CONFORMIS UNI-CONDYLAR KNEE SYSTEM?

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 UNI-CONDYLAR KNEE SYSTEM?

The FDA product code for CONFORMIS UNI-CONDYLAR KNEE SYSTEM 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.

K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus OrthopedicsK251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.K251834Persona Partial KneeZimmer BiometK251618MOTO Partial Knee System ExtensionMedacta International S.A.K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.

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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