Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
|
510(k) Number |
K032348 |
Device Name |
CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP |
Applicant |
CENTERPULSE ORTHOPEDICS, INC. |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Applicant Contact |
ROBERT M WOLFARTH |
Correspondent |
CENTERPULSE ORTHOPEDICS, INC. |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Correspondent Contact |
ROBERT M WOLFARTH |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/30/2003 |
Decision Date | 10/24/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|