Device Classification Name |
prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
|
510(k) Number |
K050966 |
Device Name |
PIVOT BIPOLAR FEMORAL HEAD |
Applicant |
ORTHO DEVELOPMENT CORP. |
12187 SOUTH BUSINESS PARK DR. |
DRAPER,
UT
84020
|
|
Applicant Contact |
WILLIAM J GRIFFIN |
Correspondent |
ORTHO DEVELOPMENT CORP. |
12187 SOUTH BUSINESS PARK DR. |
DRAPER,
UT
84020
|
|
Correspondent Contact |
WILLIAM J GRIFFIN |
Regulation Number | 888.3390
|
Classification Product Code |
|
Date Received | 04/18/2005 |
Decision Date | 07/07/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|