LANX CERVICAL SA


Device Classification Name

intervertebral fusion device with integrated fixation, cervical

510(k) Number K112388
Device Name LANX CERVICAL SA
Applicant
LANx, Inc
310 interlocken parkway,
suite 120
broomfield, 
CO 
80021

Applicant Contact michael funk
Correspondent
LANx, Inc
310 interlocken parkway,
suite 120
broomfield, 
CO 
80021

Correspodent Contact michael funk
Regulation Number 888.3080
Classification Product Code
OVE  
Date Received 08/18/2011
Decision Date 12/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No