U2 HIP SYSTEM


Device Classification Name

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

510(k) Number K111546
Device Name U2 HIP SYSTEM
Applicant
UNITED ORTHOPEDIC CORP.
no 57 park ave. 2
science park
hsinchu, 

TW

300

Applicant Contact fang-yuan ho
Correspondent
UNITED ORTHOPEDIC CORP.
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 Code
JDI  
Date Received 06/03/2011
Decision Date 07/01/2011
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