BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP


Device Classification Name

prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

510(k) Number K112019
Device Name BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP
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 888.3390
Classification Product Code
KWY  
Subsequent Product Code
LPH  
Date Received 07/14/2011
Decision Date 10/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No