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FDA 510(k)

U2 Total Knee System, PSA Tibial Insert

K-Number: K161360 · 2017-02-01

ApplicantUnited Orthopedic Corporation
Decision Date2017-02-01
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

U2 Total Knee System, PSA Tibial Insert 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 2017-02-01 under 510(k) number K161360. 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, PSA Tibial Insert?

U2 Total Knee System, PSA Tibial Insert is a medical device that received FDA 510(k) clearance on 2017-02-01. The listed applicant is United Orthopedic Corporation. The 510(k) number is K161360.

When did U2 Total Knee System, PSA Tibial Insert receive FDA 510(k) clearance?

U2 Total Knee System, PSA Tibial Insert received FDA 510(k) clearance on 2017-02-01, under 510(k) number K161360.

Who is the listed applicant for U2 Total Knee System, PSA Tibial Insert?

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 U2 Total Knee System, PSA Tibial Insert?

The FDA product code for U2 Total Knee System, PSA Tibial Insert is JWH.

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.

K252725Stem 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, #0K243024Cellbrick Knee Spacer

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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.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

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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