UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K121049
Device Name UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
Applicant
GLOBUS MEDICAL INC.
2560 general armistead ave.
audubon, 
PA 
19403

Applicant Contact meriam youssef
Correspondent
GLOBUS MEDICAL INC.
2560 general armistead ave.
audubon, 
PA 
19403

Correspodent Contact meriam youssef
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 04/06/2012
Decision Date 06/27/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized