Device Classification Name |
Appliance, Fixation, Spinal Interlaminal
|
510(k) Number |
K002733 |
Device Name |
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM |
Applicant |
DEPUY ACROMED |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767 -0350
|
|
Applicant Contact |
FRANK MASS |
Correspondent |
DEPUY ACROMED |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767 -0350
|
|
Correspondent Contact |
FRANK MASS |
Regulation Number | 888.3050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/01/2000 |
Decision Date | 12/15/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|