Locking Cage, Full XPE Cup

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

UNITED ORTHOPEDIC CORPORATION

The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for Locking Cage, Full Xpe Cup.

Pre-market Notification Details

Device IDK163441
510k NumberK163441
Device Name:Locking Cage, Full XPE Cup
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant UNITED ORTHOPEDIC CORPORATION NO 57, PARK AVE 2, SCIENCE PARK Hsinchu,  TW 300
ContactGimpel Chien
CorrespondentGimpel Chien
UNITED ORTHOPEDIC CORPORATION NO 57, PARK AVE 2, SCIENCE PARK Hsinchu,  TW 300
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-08
Decision Date2017-08-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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