ZODIC POLYAXIAL SPINAL FIXATION SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K081158
Device Name ZODIC POLYAXIAL SPINAL FIXATION 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 888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received 04/23/2008
Decision Date 07/03/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No