Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
|
510(k) Number |
K062775 |
Device Name |
EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM |
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 | 888.3358
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/18/2006 |
Decision Date | 01/16/2007 |
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
|
|
|