PROTEX CT CERVICOTHORACIC SPINAL SYSTEM


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K050391
Device Name PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
Applicant
GLOBUS MEDICAL, INC.
303 schell lane
phoenixville, 
PA 
19460

Applicant Contact kelly j baker
Correspondent
GLOBUS MEDICAL, INC.
303 schell lane
phoenixville, 
PA 
19460

Correspodent Contact kelly j baker
Regulation Number 888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNI  
Date Received 02/16/2005
Decision Date 07/21/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No