Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
|
510(k) Number |
K972393 |
Device Name |
INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI) |
Applicant |
SULZER ORTHOPEDICS, INC. |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Applicant Contact |
JACQUELYN HUGHES |
Correspondent |
SULZER ORTHOPEDICS, INC. |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Correspondent Contact |
JACQUELYN HUGHES |
Regulation Number | 888.3358
|
Classification Product Code |
|
Date Received | 06/26/1997 |
Decision Date | 09/19/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|