MECTALIF


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K110927
Device Name MECTALIF
Applicant
MEDACTA INTERNATIONAL
4725 calle quetzal, unit b
camarillo, 
CA 
93012

Applicant Contact adam gross
Correspondent
MEDACTA INTERNATIONAL
4725 calle quetzal, unit b
camarillo, 
CA 
93012

Correspodent Contact adam gross
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 03/28/2011
Decision Date 06/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No