SOLANAS AVALON POSTERIOR FIXATION SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K111076
Device Name SOLANAS AVALON POSTERIOR FIXATION SYSTEM
Applicant
ALPHATEC SPINE, INC.
5818 el camino real
carlsbad, 
CA 
92008

Applicant Contact karla schaffner
Correspondent
ALPHATEC SPINE, INC.
5818 el camino real
carlsbad, 
CA 
92008

Correspodent Contact karla schaffner
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNI  
Date Received 04/18/2011
Decision Date 07/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No