Tibial Baseplate, Tibial Insert

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

United Orthopedic Corporation

The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for Tibial Baseplate, Tibial Insert.

Pre-market Notification Details

Device IDK222700
510k NumberK222700
Device Name:Tibial Baseplate, Tibial Insert
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant United Orthopedic Corporation No 57, Park Ave 2, Science Park Hsinchu,  TW 30075
ContactLois Ho
CorrespondentLois Ho
United Orthopedic Corporation No 57, Park Ave 2, Science Park Hsinchu,  TW 30075
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-07
Decision Date2022-10-06

NIH GUDID Devices

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