LANX LATERAL


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K103666
Device Name LANX LATERAL
Applicant
LANX, INC.
390 interlocken crescent
suite 890
broomfield, 
CO 
80021

Applicant Contact alan brukholder
Correspondent
LANX, INC.
390 interlocken crescent
suite 890
broomfield, 
CO 
80021

Correspodent Contact alan brukholder
Regulation Number 888.3080
Classification Product Code
MAX  
Subsequent Product Code
MQP  
Date Received 12/15/2010
Decision Date 03/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No