Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
|
510(k) Number |
K981211 |
Device Name |
APR -T REVISION HIP STEM |
Applicant |
SULZER ORTHOPEDICS, INC. |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Applicant Contact |
SHAVAWN E PARDUHN |
Correspondent |
SULZER ORTHOPEDICS, INC. |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Correspondent Contact |
SHAVAWN E PARDUHN |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/02/1998 |
Decision Date | 05/22/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|