FDA.reportPublic FDA data

Mixed Reality Spine Navigation

Primary DI
04056481143985
Brand
Mixed Reality Spine Navigation
Company
Brainlab SE
Model
1.0
Published
2025-05-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
SBFOrthopedic Augmented Reality

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SBFOrthopedic Augmented RealityNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242569000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242569000Mixed Reality Spine NavigationBrainlab AG2025-05-16SBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481143985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481143985040564811439854056481143985

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic/optical surgical navigation/tracking systemA mobile assembly of electrically-powered devices intended to provide a physician with both electromagnetic (EM) and optical tools to track manual surgical instruments and locate target anatomical structures, commonly with respect to pre-acquired images and/or real-time data [e.g., computed tomography (CT), ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, an EM field generator, a camera, and sensors/spatial markers for attachment to the patient and instruments for position/movement tracking. It is used for multiple procedures (e.g., craniotomy) in various fields [e.g., ear/nose/throat (ENT), craniomaxillofacial (CMF) surgery].

Regulatory Flags#

DUNS number
314482980
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056481147969Spine and Trauma Navigation3.12026-10-19
04056481145200DISPOSABLE FIXATION PIN 4.0 MM X 125 MM (10 PCS)549292023-10-17
04056481146702Curve Navigation177022025-10-13
04056481146054Patient Reference Rod-Clamp Spine & Trauma558262025-09-19
04056481145439PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S558242025-06-17
04056481145446PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE L558252025-06-17
04056481144906Spine &Trauma Navigation3.02024-11-14
04056481146238PATIENT REFERENCE ARRAY SPINE & TRAUMA55761B2024-11-14
04056481146603ADAPTER SHORT FOR PATIENT REFERENCE CLAMP55761-01B2024-11-14
04056481146610ADAPTER X-PRESS FOR PATIENT REFERENCE ARRAY52419A2024-11-14
04056481144753Drill Guide Array51839-032024-06-04
04056481144760Drill Guide Depth Control (60 - 100 mm)51839-022024-06-04
04056481144777Drill Guide Depth Control (0 - 60 mm)51839-012024-06-04
04056481144784Drill Guide Tube (4.5 mm)51839-452024-06-04
04056481144791Drill Guide Tube (3.2 mm)51839-322024-06-04
04056481144807Drill Guide Tube (2.6 mm)51839-262024-06-04
04056481144814Drill Guide Tube (2.4 mm)51839-242024-06-04
04056481144821Drill Guide Tube (2.0 mm)51839-202024-06-04
04056481144838Drill Guide Handle518392024-06-04
04056481145057Drill Guide Trocar Insert (2.0 mm)51839-932024-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630345729316NextAR TSA PlatformMedacta International SASBF2026-04-13
07630345725912NextAR Spine PlatformMedacta International SASBF2026-01-20
07630542722332NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542759130NextAR™ SpineMedacta International SASBF2025-11-14
07630542759147NextAR™ SpineMedacta International SASBF2025-11-14
07630542720390NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720406NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720413NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720420NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720437NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720444NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720451NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542765346NextAR (TM) Shoulder PlatformMedacta International SASBF2025-09-17
07630542765353NextAR (TM) Shoulder PlatformMedacta International SASBF2025-09-17
07630542765360NextAR (TM) Shoulder PlatformMedacta International SASBF2025-09-17
07630542765421NextAR (TM) Shoulder PlatformMedacta International SASBF2025-09-17
07630542765438NextAR (TM) Shoulder PlatformMedacta International SASBF2025-09-17
07630542765445NextAR (TM) Shoulder PlatformMedacta International SASBF2025-09-17
04056481146672Mixed Reality Spine NavigationBrainlab SESBF2025-07-31
00810180350013ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDSBF2025-07-29
07630542735448NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735455NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735462NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735479NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735486NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735493NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735509NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735516NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735523NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735530NextAR Spine PlatformMedacta International SASBF2024-12-03