United U2 Femoral Head, 22mm Delta Ceramic Head

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

United Orthopedic Corporation

The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for United U2 Femoral Head, 22mm Delta Ceramic Head.

Pre-market Notification Details

Device IDK221675
510k NumberK221675
Device Name:United U2 Femoral Head, 22mm Delta Ceramic Head
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
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 City,  TW
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-09
Decision Date2022-11-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04719886890846 K221675 000
04719886890839 K221675 000
04719886890822 K221675 000

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