Device Classification Name |
appliance, fixation, spinal interlaminal
|
510(k) Number |
K142253 |
Device Name |
SOLSTICE OCT System |
Applicant |
LIFE SPINE, INC |
2401 W. HASSELL RD SUITE 1535 |
HOFFMAN ESTATES,
IL
60169
|
|
Applicant Contact |
Randy Lewis |
Correspondent |
LIFE SPINE, INC |
13951 South Quality Drive |
Huntley,
IL
60142
|
|
Correspondent Contact |
Randy Lewis |
Regulation Number | 888.3050
|
Classification Product Code |
|
Date Received | 08/14/2014 |
Decision Date | 04/23/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|