RAPTOR FACET FIXATION SYSTEM


Device Classification Name

system, facet screw spinal device

510(k) Number K110170
Device Name RAPTOR FACET FIXATION SYSTEM
Applicant
ALPHATEC SPINE, INC.
5818 el camino real
carlsbad, 
CA 
92008

Applicant Contact olga lewis
Correspondent
ALPHATEC SPINE, INC.
5818 el camino real
carlsbad, 
CA 
92008

Correspodent Contact olga lewis
Classification Product Code
MRW  
Date Received 01/20/2011
Decision Date 11/28/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No