ZAVATION IBF SYSTEMS


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K112664
Device Name ZAVATION IBF SYSTEMS
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 888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received 09/13/2011
Decision Date 12/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No