U-MOTION II ACETABULAR SYSTEM


Device Classification Name

prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

510(k) Number K122185
Device Name U-MOTION II ACETABULAR SYSTEM
Applicant
UNITED ORTHOPEDIC CORP.
57 park ave. 2, science park
hsinchu, 

TW

300

Applicant Contact fang-yuan ho
Correspondent
UNITED ORTHOPEDIC CORP.
57 park ave. 2, science park
hsinchu, 

TW

300

Correspodent Contact fang-yuan ho
Regulation Number 888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWY   LWJ   MEH  
Date Received 07/23/2012
Decision Date 02/22/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No