SPINEASSIST DEVICE

Device Classification Name

neurological stereotaxic instrument

510(k) Number K033413
Device Name SPINEASSIST DEVICE
Applicant
MAZOR SURGICAL TECHNOLOGIES LTD.
beit hapa’amon box 124
20 hata’as (room 213)
kfar saba, 

IL

44425

Applicant Contact ahava stein
Correspondent
MAZOR SURGICAL TECHNOLOGIES LTD.
beit hapa’amon box 124
20 hata’as (room 213)
kfar saba, 

IL

44425

Correspodent Contact ahava stein
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 10/27/2003
Decision Date 01/07/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No