XENON(TM) PEDICLE SCREW SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K111634
Device Name XENON(TM) PEDICLE SCREW SYSTEM
Applicant
ALPHATEC SPINE, INC.
5818 el camino real
carlsbad, 
CA 
92008

Applicant Contact cheryl allen
Correspondent
ALPHATEC SPINE, INC.
5818 el camino real
carlsbad, 
CA 
92008

Correspodent Contact cheryl allen
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received 06/13/2011
Decision Date 01/25/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No