Device Classification Name |
prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
|
510(k) Number |
K954800 |
Device Name |
APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI) |
Applicant |
INTERMEDICS ORTHOPEDICS |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Applicant Contact |
BARRY J HASSETT |
Correspondent |
INTERMEDICS ORTHOPEDICS |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Correspondent Contact |
BARRY J HASSETT |
Regulation Number | 888.3353
|
Classification Product Code |
|
Date Received | 09/27/1995 |
Decision Date | 04/25/1996 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|