CANOPY LAMINOPLASTY FIXATION SYSTEM


Device Classification Name

orthosis, spine, plate, laminoplasty, metal

510(k) Number K121732
Device Name CANOPY LAMINOPLASTY FIXATION SYSTEM
Applicant
GLOBUS MEDICAL INC.
2560 general armistead ave.
audubon, 
PA 
19403

Applicant Contact sarah marie fitzgerald
Correspondent
GLOBUS MEDICAL INC.
2560 general armistead ave.
audubon, 
PA 
19403

Correspodent Contact sarah marie fitzgerald
Regulation Number 888.3050
Classification Product Code
NQW  
Date Received 06/13/2012
Decision Date 10/31/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No