LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K103660
Device Name LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
Applicant
LANX, INC.
390 interlocken crescent
suite 890
broomfield, 
CO 
80021

Applicant Contact william sandul
Correspondent
LANX, INC.
390 interlocken crescent
suite 890
broomfield, 
CO 
80021

Correspodent Contact william sandul
Regulation Number 888.3080
Classification Product Code
ODP  
Subsequent Product Code
MQP  
Date Received 12/15/2010
Decision Date 02/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No