Device Classification Name |
appliance, fixation, spinal interlaminal
|
510(k) Number |
K150229 |
Device Name |
SOLSTICE OCT System |
Applicant |
LIFE SPINE, INC |
13951 S Quality Drive |
Huntley,
IL
60142
|
|
Applicant Contact |
Randy Lewis |
Correspondent |
LIFE SPINE, INC |
13951 S Quality Drive |
Huntley,
IL
60142
|
|
Correspondent Contact |
Randy Lewis |
Regulation Number | 888.3050
|
Classification Product Code |
|
Date Received | 02/02/2015 |
Decision Date | 04/07/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|