Device Classification Name |
Intervertebral Fusion Device With Integrated Fixation, Cervical
|
510(k) Number |
K112068 |
Device Name |
SYNTHES ZERO-P VARIABLE ANGLE (VA) |
Applicant |
SYNTHES SPINE CO.LP |
1302 WRIGHTS LANE EAST |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
STACEY BONNELL |
Correspondent |
SYNTHES SPINE CO.LP |
1302 WRIGHTS LANE EAST |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
STACEY BONNELL |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 07/20/2011 |
Decision Date | 11/07/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|