Device Classification Name |
Orthosis, Spinal Pedicle Fixation
|
510(k) Number |
K030377 |
Device Name |
MODIFICATION TO SYNTHES CERVIFIX SYSTEM |
Applicant |
SYNTHES (USA) |
1690 RUSSELL RD. |
PAOLI,
PA
19301
|
|
Applicant Contact |
VIKKI M HOFFMAN |
Correspondent |
SYNTHES (USA) |
1690 RUSSELL RD. |
PAOLI,
PA
19301
|
|
Correspondent Contact |
VIKKI M HOFFMAN |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/05/2003 |
Decision Date | 03/06/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|