Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
|
510(k) Number |
K122305 |
Device Name |
CORIN TRINITY-I ACETABULAR SHELL |
Applicant |
CORIN USA |
10500 UNIVERSITY CENTER DRIVE |
SUITE 190 |
TAMPA,
FL
33612
|
|
Applicant Contact |
DIANA L MARTONE |
Correspondent |
CORIN USA |
10500 UNIVERSITY CENTER DRIVE |
SUITE 190 |
TAMPA,
FL
33612
|
|
Correspondent Contact |
DIANA L MARTONE |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/01/2012 |
Decision Date | 11/21/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|