Device Classification Name |
Spinous Process Plate
|
510(k) Number |
K121924 |
Device Name |
INTEGRA INTERSPINOUS PROCESS SYSTEM |
Applicant |
SEASPINE, INC. |
2302 la Mirada Dr |
VISTA,
CA
92081
|
|
Applicant Contact |
NICK M CORDARO |
Correspondent |
SEASPINE, INC. |
2302 la Mirada Dr |
VISTA,
CA
92081
|
|
Correspondent Contact |
NICK M CORDARO |
Regulation Number | 888.3050
|
Classification Product Code |
|
Date Received | 07/02/2012 |
Decision Date | 09/04/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|