RELIEVE LAMINOPLASTY FIXATION SYSTEM


Device Classification Name

orthosis, spine, plate, laminoplasty, metal

510(k) Number K080664
Device Name RELIEVE LAMINOPLASTY FIXATION SYSTEM
Applicant
GLOBUS MEDICAL, INC.
2560 general armistead ave.
valley forge business center
audubon, 
PA 
19403

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

Correspodent Contact kelly j baker
Regulation Number 888.3050
Classification Product Code
NQW  
Date Received 03/10/2008
Decision Date 07/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No