Device Classification Name |
prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
|
510(k) Number |
K962448 |
Device Name |
PRIMALOC CEMENTED HIP SYSTEM |
Applicant |
ORTHO DEVELOPMENT CORP. |
106 WEST 12200 SOUTH |
DRAPER,
UT
84020
|
|
Applicant Contact |
MICHELLE M PERRY |
Correspondent |
ORTHO DEVELOPMENT CORP. |
106 WEST 12200 SOUTH |
DRAPER,
UT
84020
|
|
Correspondent Contact |
MICHELLE M PERRY |
Regulation Number | 888.3390
|
Classification Product Code |
|
Date Received | 06/24/1996 |
Decision Date | 09/19/1996 |
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
|
|
|