Device Classification Name |
appliance, fixation, spinal interlaminal
|
510(k) Number |
K122509 |
Device Name |
VERTIFLEX SPINOUS PROCESS FIXATION PLATE |
Applicant |
VERTIFLEX, INC. |
1351 CALLE AVANZADO |
SAN CLAMENTE,
CA
92673
|
|
Applicant Contact |
STEVE REITZLER |
Correspondent |
VERTIFLEX, INC. |
1351 CALLE AVANZADO |
SAN CLAMENTE,
CA
92673
|
|
Correspondent Contact |
STEVE REITZLER |
Regulation Number | 888.3050
|
Classification Product Code |
|
Date Received | 08/17/2012 |
Decision Date | 12/17/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|