Device Classification Name |
Orthosis, Spinal Pedicle Fixation
|
510(k) Number |
K033826 |
Device Name |
ORTHOPEDIC ALLIANCE SPINE SYSTEM |
Applicant |
ORTHOPEDIC ALLIANCE LLC |
41558 EASTMAN DRIVE |
SUITE A |
MARIETTA,
CA
92562
|
|
Applicant Contact |
ROGER WILLIAMS |
Correspondent |
ORTHOPEDIC ALLIANCE LLC |
41558 EASTMAN DRIVE |
SUITE A |
MARIETTA,
CA
92562
|
|
Correspondent Contact |
ROGER WILLIAMS |
Regulation Number | 888.3070
|
Classification Product Code |
|
Date Received | 12/10/2003 |
Decision Date | 07/01/2004 |
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
|
|
|