BENCOX II STEM, BENCOX METAL HEAD


Device Classification Name

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

510(k) Number K122099
Device Name BENCOX II STEM, BENCOX METAL HEAD
Applicant
CORENTEC CO., LTD
11th chungho tower, 748-1 banpo 1 dong
seocho gu, seoul, 

KR

137-040

Applicant Contact j.s. daniel
Correspondent
CORENTEC CO., LTD
11th chungho tower, 748-1 banpo 1 dong
seocho gu, seoul, 

KR

137-040

Correspodent Contact j.s. daniel
Regulation Number 888.3358
Classification Product Code
LPH  
Subsequent Product Code
KWY  
Date Received 07/16/2012
Decision Date 10/05/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No