ZAVATION CERVICAL PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K112533
Device Name ZAVATION CERVICAL PLATE 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 888.3060
Classification Product Code
KWQ  
Date Received 08/29/2011
Decision Date 12/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No