NAUTILUS SPINAL SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K111953
Device Name NAUTILUS SPINAL SYSTEM
Applicant
LIFE SPINE
2401 w. hassell rd.
suite 1535
hoffman estates, 
IL 
60169

Applicant Contact randy lewis
Correspondent
LIFE SPINE
2401 w. hassell rd.
suite 1535
hoffman estates, 
IL 
60169

Correspodent Contact randy lewis
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received 07/11/2011
Decision Date 08/07/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No