FDA.reportPublic FDA data

Mixed Reality Spine Navigation

Primary DI
04056481146672
Brand
Mixed Reality Spine Navigation
Company
Brainlab SE
Model
1.1
Published
2025-07-31
Public version status
Update
Distribution status
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
04056481146672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481146672040564811466724056481146672

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
04056481147648Quip Link Instrument Tracking Array For 3 Marker Spheres M581932026-10-29
04056481147655Quip Link Instrument Tracking Array For 3 Marker Spheres ML581942026-10-29
04056481147662Quip Link Instrument Tracking Array For 3 Marker Spheres L581952026-10-29
04056481147679Quip Link Instrument Tracking Array For 3 Marker Spheres L1581962026-10-29
04056481147686Quip Link Instrument Tracking Array For 3 Marker Spheres L2581972026-10-29
04056481147693Quip Instrument Adapter Clamp Size S582102026-10-29
04056481147709Quip Instrument Adapter Clamp Softgrip Size M582112026-10-29
04056481147716Quip Instrument Adapter Clamp Softgrip Size L582122026-10-29
04056481147723Quip Instrument Adapter Clamp Softgrip Size XL582132026-10-29
04056481147730Quip Instrument Adapter Clamp For Rectangular Instruments582142026-10-29
04056481147747Quip Instrument Adapter Clamp For Cylindrical Instruments582152026-10-29
04056481147754Quip Instrument Adapter Extension 50 mm582162026-10-29
04056481147761Quip Instrument Adapter 45° Angled582172026-10-29
04056481145323Patient Reference Carbon-Clamp Spine & Trauma558232026-10-27
04056481148201Sterilization Tray Accessories Spine52306C2026-10-27
04056481148218Sterilization Tray Accessories Spine & Trauma52326A2026-10-27
04056481148225Sterilization Tray Accessories Spine MIS52313B2026-10-27
04056481148232Sterilization Tray Accessories ENT/CMF52311A2026-10-27
04056481148249Sterilization Tray Accessories Cranial (2 of 2)52305A2026-10-27
04056481146207Spine Planning3.02026-10-23

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
00810180350013ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDSBF2025-07-29
04056481143985Mixed Reality Spine NavigationBrainlab SESBF2025-05-31
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