Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
|
510(k) Number |
K162127 |
Device Name |
Bencox M Stem Lateralized & Bencox Mirabo Cup System |
Applicant |
CORENTEC CO., LTD |
12, YEONGSANHONG 1-GIL, IPJANG-MYEON, SEOBUK GU |
CHEONAN-SI,
KR
31056
|
|
Applicant Contact |
J. S. DANIEL |
Correspondent |
CORENTEC CO., LTD |
8F CHUNGHO TOWER, 483, GANGNAM-DAERO |
SEOCHO GU |
SEOUL,
KR
06541
|
|
Correspondent Contact |
J. S. DANIEL |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/01/2016 |
Decision Date | 12/05/2016 |
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
|
|
|