UNITED UTF STEM


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

510(k) Number K110245
Device Name UNITED UTF STEM
Applicant
UNITED ORTHOPEDIC CORPORATION
no 57, park ave 2,
science park
hsinchu, 

TW

300

Applicant Contact fang-yuan ho
Correspondent
UNITED ORTHOPEDIC CORPORATION
no 57, park ave 2,
science park
hsinchu, 

TW

300

Correspodent Contact fang-yuan ho
Regulation Number 888.3358
Classification Product Code
LPH  
Subsequent Product Codes
KWY   LZO  
Date Received 01/27/2011
Decision Date 08/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls