Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
|
510(k) Number |
K103431 |
Device Name |
COREN TOTAL HIP SYSTEM |
Applicant |
CORENTEC CO., LTD |
11234 EL CAMINO REAL |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
KEVIN A THOMAS |
Correspondent |
CORENTEC CO., LTD |
11234 EL CAMINO REAL |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
KEVIN A THOMAS |
Regulation Number | 888.3358
|
Classification Product Code |
|
Date Received | 11/23/2010 |
Decision Date | 07/21/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|