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FDA 510(k)

CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM

K-Number: K052687 · 2006-08-31

ApplicantConformis, Inc.
Decision Date2006-08-31
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONFORMIS, INC. TOTAL KNEE REPAIR 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 2006-08-31 under 510(k) number K052687. 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 CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM?

CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM is a medical device that received FDA 510(k) clearance on 2006-08-31. The listed applicant is Conformis, Inc.. The 510(k) number is K052687.

When did CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM receive FDA 510(k) clearance?

CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM received FDA 510(k) clearance on 2006-08-31, under 510(k) number K052687.

Who is the listed applicant for CONFORMIS, INC. TOTAL KNEE REPAIR 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, INC. TOTAL KNEE REPAIR SYSTEM?

The FDA product code for CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM is JWH.

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Related Devices (Code: JWH)

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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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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