Device Classification Name |
appliance, fixation, spinal intervertebral body
|
510(k) Number |
K071667 |
Device Name |
SYNTHES VECTRA-ONE SYSTEM |
Applicant |
SYNTHES SPINE |
1302 WRIGHTS LANE EAST |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
STACEY BONNELL |
Correspondent |
SYNTHES SPINE |
1302 WRIGHTS LANE EAST |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
STACEY BONNELL |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 06/19/2007 |
Decision Date | 11/30/2007 |
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
|
|
|