VAULT ALIF SYSTEM


Device Classification Name

intervertebral fusion device with integrated fixation, lumbar

510(k) Number K103369
Device Name VAULT ALIF SYSTEM
Applicant
SPINAL USA
2050 executive dr.
pearl, 
MS 
39208

Applicant Contact linda polk
Correspondent
SPINAL USA
2050 executive dr.
pearl, 
MS 
39208

Correspodent Contact linda polk
Regulation Number 888.3080
Classification Product Code
OVD  
Date Received 11/17/2010
Decision Date 04/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No