Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K060577 |
Device Name |
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS |
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 | 888.3353
|
Classification Product Code |
|
Date Received | 03/06/2006 |
Decision Date | 04/28/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|