Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K073467 |
Device Name |
SPINEASSIST SYSTEM |
Applicant |
MAZOR SURGICAL TECHNOLOGIES LTD. |
20 HATA'AS ST. |
KFAR SABA,
IL
44425
|
|
Applicant Contact |
AHAVA STEIN |
Correspondent |
MAZOR SURGICAL TECHNOLOGIES LTD. |
20 HATA'AS ST. |
KFAR SABA,
IL
44425
|
|
Correspondent Contact |
AHAVA STEIN |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 12/10/2007 |
Decision Date | 05/23/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|