LANX SPINAL FIZATION SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K121316
Device Name LANX SPINAL FIZATION SYSTEM
Applicant
LANX, INC.
310 interlocken parkway
suite 120
broomfield, 
CO 
80021

Applicant Contact william sandul
Correspondent
LANX, INC.
310 interlocken parkway
suite 120
broomfield, 
CO 
80021

Correspodent Contact william sandul
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received 05/02/2012
Decision Date 09/10/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No