Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K960588 |
Device Name |
WAGNER REVISION STEM |
Applicant |
INTERMEDICS ORTHOPEDICS |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Applicant Contact |
JACQUELYN HUGHES |
Correspondent |
INTERMEDICS ORTHOPEDICS |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Correspondent Contact |
JACQUELYN HUGHES |
Regulation Number | 888.3353
|
Classification Product Code |
|
Date Received | 02/12/1996 |
Decision Date | 08/05/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|