REVLOK FENESTRATED SCREW SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K110280
Device Name REVLOK FENESTRATED SCREW SYSTEM
Applicant
GLOBUS MEDICAL INC.
2560 general armistead ave.
audubon, 
PA 
19403

Applicant Contact kelly j baker
Correspondent
GLOBUS MEDICAL INC.
2560 general armistead ave.
audubon, 
PA 
19403

Correspodent Contact kelly j baker
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWQ   MNH   MNI  
Date Received 01/31/2011
Decision Date 07/06/2011
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No