Device Classification Name |
Thoracolumbosacral Pedicle Screw System
|
510(k) Number |
K150390 |
Device Name |
Nautilus Spinal 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 | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/18/2015 |
Decision Date | 03/16/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|