FDA.report

510(k) K252847

Device
NextAR Hip Platform
Applicant
Medacta International S.A.
510(k) number
K252847
Product code
SBF
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-09
Date received
2025-09-08
Regulation
882.4560
Classification name
Orthopedic Augmented Reality
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Stefano Baj
Address
Strada Regina Castel San Pietro CH 6874 6874

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
07630542785283NextAR Hip PlatformMedacta International SA2026-01-14
07630542722332NextAR Hip PlatformMedacta International SA2026-01-14
07630542779626NextAR Hip PlatformMedacta International SA2026-01-14
07630542782183NextAR Hip PlatformMedacta International SA2026-01-14
07630542782190NextAR Hip PlatformMedacta International SA2026-01-14
07630542782206NextAR Hip PlatformMedacta International SA2026-01-14
07630542782213NextAR Hip PlatformMedacta International SA2026-01-14
07630542782220NextAR Hip PlatformMedacta International SA2026-01-14
07630542782237NextAR Hip PlatformMedacta International SA2026-01-14
07630542782466NextAR Hip PlatformMedacta International SA2026-01-14
07630542782473NextAR Hip PlatformMedacta International SA2026-01-14
07630542782480NextAR Hip PlatformMedacta International SA2026-01-14
07630542782497NextAR Hip PlatformMedacta International SA2026-01-14
07630542782503NextAR Hip PlatformMedacta International SA2026-01-14
07630542785986NextAR Hip PlatformMedacta International SA2026-01-14
07630542785399NextAR Hip PlatformMedacta International SA2026-01-14
07630542785405NextAR Hip PlatformMedacta International SA2026-01-14
07630542785658NextAR Hip PlatformMedacta International SA2026-01-14
07630542785665NextAR Hip PlatformMedacta International SA2026-01-14
07630542785672NextAR Hip PlatformMedacta International SA2026-01-14
07630542785689NextAR Hip PlatformMedacta International SA2026-01-14
07630542785696NextAR Hip PlatformMedacta International SA2026-01-14
07630542785702NextAR Hip PlatformMedacta International SA2026-01-14
07630542785719NextAR Hip PlatformMedacta International SA2026-01-14
07630542785955NextAR Hip PlatformMedacta International SA2026-01-14
07630542785962NextAR Hip PlatformMedacta International SA2026-01-14
07630542785979NextAR Hip PlatformMedacta International SA2026-01-14

Other 510(k) Records For Product Code SBF

510(k)DeviceApplicantDecision date
K253805Knee+Pixee Medical S.A.S.2026-04-24
K251639xvision Spine systemAugmedics, Ltd.2025-10-03
K252054SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.2025-09-29
K252530OptiVu™ ShoulderMr Surgical Solutions, LLC2025-09-10
K251737NextAR(TM) Shoulder PlatformMedacta International S.A.2025-09-04
K252170OptiVu™ ShoulderMr Surgical Solutions, LLC2025-08-08
K250477NextAR(TM) SpineMedacta International S.A.2025-07-31
K250108OptiVu™ ShoulderMr Surgical Solutions, LLC2025-07-09
K241525ExcelsiusXR™Globus Medical, Inc.2025-07-08
K242569Mixed Reality Spine NavigationBrainlab AG2025-05-16
K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited2025-03-21
K243975Knee+Pixee Medical2025-03-20
K250255xvision Spine systemAugmedics, Ltd.2025-03-13
K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.2025-01-13
K243623SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.2024-12-24