Device Classification Name |
orthopedic stereotaxic instrument
|
510(k) Number |
K223350 |
Device Name |
Remi Robotic Navigation System |
Applicant |
Fusion Robotics, LLC |
168 Centennial Parkway |
Unit 170 |
Louisville,
CO
80027
|
|
Applicant Contact |
Sarah Braun |
Correspondent |
Integrity Implants Inc. dba Accelus |
354 Hiatt Drive |
Palm Beach Gardens,
FL
33418
|
|
Correspondent Contact |
Sarah Braun |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 11/02/2022 |
Decision Date | 03/13/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|