LANX INTERVERTEBRAL BODY FUSION DEVICE


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K073144
Device Name LANX INTERVERTEBRAL BODY FUSION DEVICE
Applicant
LANX, LLC
390 interlocken crescent
suite 890
broomfield, 
CO 
80021

Applicant Contact greg causey
Correspondent
LANX, LLC
390 interlocken crescent
suite 890
broomfield, 
CO 
80021

Correspodent Contact greg causey
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 11/07/2007
Decision Date 01/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No