Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K062146 |
Device Name |
UNI KNEE SURGETICS NAVIGATION SYSTEM |
Applicant |
PRAXIM S.A |
LE GRAND SABLON |
4 AVENUE DE L'OBIOU |
LA TRONCHE,
FR
38700
|
|
Applicant Contact |
MADY BATAILH |
Correspondent |
PRAXIM S.A |
LE GRAND SABLON |
4 AVENUE DE L'OBIOU |
LA TRONCHE,
FR
38700
|
|
Correspondent Contact |
MADY BATAILH |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 07/27/2006 |
Decision Date | 08/21/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|