Device Classification Name |
Orthopedic Stereotaxic Instrument
|
510(k) Number |
K221618 |
Device Name |
Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System |
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 | 06/03/2022 |
Decision Date | 08/30/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|