Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
More FDA Info for this Device |
510(K) Number |
K172806 |
Device Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
Applicant |
Corentec Co., Ltd
12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk Gu
Cheonan-si 31056 KR
Other 510(k) Applications for this Company
|
Contact |
J. S. Daniel
Other 510(k) Applications for this Contact |
Regulation Number |
888.3358
More FDA Info for this Regulation Number |
Classification Product Code |
LPH
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
09/18/2017 |
Decision Date |
10/17/2017 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OR - Orthopedic |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
Summary |
Type |
Special |
Reviewed By Third Party |
N |
Expedited Review |
|