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FDA 510(k)

UNITED U2 XPE TOTAL KNEE SYSTEM

K-Number: K103733 · 2011-08-02

ApplicantUnited Orthopedic Corporation
Decision Date2011-08-02
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNITED U2 XPE TOTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corporation. It received FDA 510(k) clearance on 2011-08-02 under 510(k) number K103733. 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 UNITED U2 XPE TOTAL KNEE SYSTEM?

UNITED U2 XPE TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-08-02. The listed applicant is United Orthopedic Corporation. The 510(k) number is K103733.

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

UNITED U2 XPE TOTAL KNEE SYSTEM received FDA 510(k) clearance on 2011-08-02, under 510(k) number K103733.

Who is the listed applicant for UNITED U2 XPE TOTAL KNEE SYSTEM?

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

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

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

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Other records listing United Orthopedic Corporation 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.

K253948Momentum Acetabular Cup SystemK252725Stem Extension Line (U2 Total Knee System—PSA Type)K252303Stem Extension Line (USTAR II System)K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaK242315Resolve Modular Revision Hip StemK243466Conformity Stem Extension Line, #0

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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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