Device Classification Name |
Appliance, Fixation, Spinal Intervertebral Body
|
510(k) Number |
K032368 |
Device Name |
SONOMA ANTERIOR CERVICAL PLATE SYSTEM |
Applicant |
SEASPINE |
727 PARK BLVD. |
SAN DIEGO,
CA
92101
|
|
Applicant Contact |
DIANA SMITH |
Correspondent |
SEASPINE |
727 PARK BLVD. |
SAN DIEGO,
CA
92101
|
|
Correspondent Contact |
DIANA SMITH |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 08/01/2003 |
Decision Date | 10/09/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|