Device Classification Name |
Orthopedic Stereotaxic Instrument
|
510(k) Number |
K182104 |
Device Name |
NavLock Trackers, Robotic Reference Frame |
Applicant |
Medtronic Navigation |
826 Coal Creek Circle |
Louisville,
CO
80027
|
|
Applicant Contact |
Jainam Shah |
Correspondent |
Medtronic Navigation |
826 Coal Creek Circle |
Louisville,
CO
80027
|
|
Correspondent Contact |
Jainam Shah |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 08/03/2018 |
Decision Date | 11/02/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|