Device Classification Name |
orthopedic stereotaxic instrument
|
510(k) Number |
K090953 |
Device Name |
TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK |
Applicant |
PRAXIM MEDIVISION, SA |
LE GRAND SABLON |
4 AVENUE DE L'OBIOU |
LA TRONCHE,
FR
38700
|
|
Applicant Contact |
SEBASTIEN BURTIN |
Correspondent |
PRAXIM MEDIVISION, SA |
LE GRAND SABLON |
4 AVENUE DE L'OBIOU |
LA TRONCHE,
FR
38700
|
|
Correspondent Contact |
SEBASTIEN BURTIN |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 04/03/2009 |
Decision Date | 01/21/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|