MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM

Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K071380
Device Name MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM
Applicant
ALPHATEC SPINE, INC.
2051 palomar airport road
suite 100
carlsbad, 
CA 
92011

Applicant Contact paula morgan
Correspondent
ALPHATEC SPINE, INC.
2051 palomar airport road
suite 100
carlsbad, 
CA 
92011

Correspodent Contact paula morgan
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNI  
Date Received 05/17/2007
Decision Date 08/20/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls