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FDA 510(k)

U2 TOTAL KNEE SYSTEM

K-Number: K051640 · 2006-03-01

ApplicantUnited Orthopedic Corp.
Decision Date2006-03-01
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

U2 TOTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corp.. It received FDA 510(k) clearance on 2006-03-01 under 510(k) number K051640. 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 U2 TOTAL KNEE SYSTEM?

U2 TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2006-03-01. The listed applicant is United Orthopedic Corp.. The 510(k) number is K051640.

When did U2 TOTAL KNEE SYSTEM receive FDA 510(k) clearance?

U2 TOTAL KNEE SYSTEM received FDA 510(k) clearance on 2006-03-01, under 510(k) number K051640.

Who is the listed applicant for U2 TOTAL KNEE SYSTEM?

The FDA 510(k) record lists United Orthopedic Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U2 TOTAL KNEE SYSTEM?

The FDA product code for U2 TOTAL KNEE SYSTEM is JWH.

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Other records listing United Orthopedic Corp. as applicant

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.

K132455U-MOTION II PS+ CUPK122185U-MOTION II ACETABULAR SYSTEMK122183AUGMENT AND SCREW, PSA TYPEK121777U2 ACETABULAR CUP, PLASMA SPRAYK111546U2 HIP SYSTEMK103497CERAMIC FEMORAL HEAD

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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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