ZAVATION SPINAL SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K112484
Device Name ZAVATION SPINAL SYSTEM
Applicant
ZAVATION LLC
501 avalon way
brandon, 
MS 
39047

Applicant Contact john walker
Correspondent
ZAVATION LLC
501 avalon way
brandon, 
MS 
39047

Correspodent Contact john walker
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received 08/29/2011
Decision Date 11/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No