GENESYS SPINE TILOCK SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K103671
Device Name GENESYS SPINE TILOCK SYSTEM
Applicant
GENESYS SPINE
1250 capital of texas hwy so.
building three, suite 600
austin, 
TX 
78746

Applicant Contact brian j bergeron
Correspondent
GENESYS SPINE
1250 capital of texas hwy so.
building three, suite 600
austin, 
TX 
78746

Correspodent Contact brian j bergeron
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received 12/16/2010
Decision Date 07/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No