Device Classification Name |
Intervertebral Fusion Device With Integrated Fixation, Cervical
|
510(k) Number |
K122008 |
Device Name |
INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE |
Applicant |
INCITE INNOVATION LLC |
1500 MAIN STREET |
STE. 2410 |
SPRINGFIELD,
MA
01115
|
|
Applicant Contact |
JOHN KIRWAN |
Correspondent |
INCITE INNOVATION LLC |
1500 MAIN STREET |
STE. 2410 |
SPRINGFIELD,
MA
01115
|
|
Correspondent Contact |
JOHN KIRWAN |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 07/09/2012 |
Decision Date | 11/16/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|