CERAMIC FEMORAL HEAD


Device Classification Name

prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

510(k) Number K103497
Device Name CERAMIC FEMORAL HEAD
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
MEH  
Subsequent Product Codes
LPH   LWJ  
Date Received 11/29/2010
Decision Date 03/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No