Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K081232 |
Device Name |
TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES |
Applicant |
PRAXIM |
LE GRAND SABLON |
4 AVENUE DE L'OBIOU |
LA TRONCHE,
FR
38700
|
|
Applicant Contact |
ANNIE POLLIER |
Correspondent |
PRAXIM |
LE GRAND SABLON |
4 AVENUE DE L'OBIOU |
LA TRONCHE,
FR
38700
|
|
Correspondent Contact |
ANNIE POLLIER |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 05/01/2008 |
Decision Date | 08/06/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|