UNITED 36MM CERAMIC FEMORAL HEAD, DELTA


Device Classification Name

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

510(k) Number K112463
Device Name UNITED 36MM CERAMIC FEMORAL HEAD, DELTA
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 888.3353
Classification Product Code
LZO  
Subsequent Product Codes
LPH   MEH  
Date Received 08/26/2011
Decision Date 09/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls