Device Classification Name |
intervertebral fusion device with integrated fixation, cervical
|
510(k) Number |
K121852 |
Device Name |
SYNTHES ZERO-P VARIABLE ANGLE (VA) |
Applicant |
SYNTHES SPINE CO.LP |
1302 WRIGHTS LANE EAST |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
MONIKA MCDOLE-RUSSELL |
Correspondent |
SYNTHES SPINE CO.LP |
1302 WRIGHTS LANE EAST |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
MONIKA MCDOLE-RUSSELL |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 06/25/2012 |
Decision Date | 07/25/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|