NOVEL SPINAL SPACER SYSTEM


Device Classification Name

spinal vertebral body replacement device

510(k) Number K080699
Device Name NOVEL SPINAL SPACER SYSTEM
Applicant
ALPHATEC SPINE, INC.
2051 palomar airport road
suite 100
carlsbad, 
CA 
92011

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

Correspodent Contact mary stanners
Regulation Number 888.3060
Classification Product Code
MQP  
Subsequent Product Code
MAX  
Date Received 03/12/2008
Decision Date 05/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No