Device Classification Name |
appliance, fixation, spinal intervertebral body
|
510(k) Number |
K073232 |
Device Name |
INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX |
Applicant |
SPINEFRONTIER, INC. |
100 CUMMINGS CENTER |
SUITE 240C |
BEVERLY,
MA
01915
|
|
Applicant Contact |
THOMAS A CARLSON |
Correspondent |
SPINEFRONTIER, INC. |
100 CUMMINGS CENTER |
SUITE 240C |
BEVERLY,
MA
01915
|
|
Correspondent Contact |
THOMAS A CARLSON |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 11/15/2007 |
Decision Date | 02/20/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|