Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
|
510(k) Number |
K120924 |
Device Name |
BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG |
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
|
|
Correspondent Contact |
J.S. DANIEL |
Regulation Number | 888.3358 |
Classification Product Code |
|
Date Received | 03/27/2012 |
Decision Date | 09/10/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|