Device Classification Name |
Orthopedic Stereotaxic Instrument
|
510(k) Number |
K212245 |
Device Name |
Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning |
Applicant |
Brainlab AG |
Olof-Palme-Str. 9 |
Munich,
DE
81829
|
|
Applicant Contact |
Chiara Cunico |
Correspondent |
Brainlab AG |
Olof-Palme-Str. 9 |
Munich,
DE
81829
|
|
Correspondent Contact |
Chiara Cunico |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 07/19/2021 |
Decision Date | 04/13/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|