Device Classification Name |
orthopedic stereotaxic instrument
|
510(k) Number |
K120867 |
Device Name |
VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS |
Applicant |
MEDOS INTERNATIONAL SARL |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Applicant Contact |
LAURA BLEYENDAAL |
Correspondent |
MEDOS INTERNATIONAL SARL |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Correspondent Contact |
LAURA BLEYENDAAL |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 03/22/2012 |
Decision Date | 09/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|