OrthoNext Platform System

510(k) Number

K202519 ↗

FDA product code

LLZ

Device class

Class II

Regulation

21 CFR Part 892.2050

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

• DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY by Planar Systems, Inc.
• TheraSphere 360™ Y-90 Management Platform by Boston Scientific
• DBSWIN, VISTAEASY by DÜRR DENTAL SE
• Efficient Care 3D Planning by Orthosoft Inc. (d/b/a) Zimmer CAS
• CERNER PROVISION WORKSTATION (VERSION 2.5) by Cerner Corporation
• MAMMOVISTA B.smart by SIEMENS MEDICAL SOLUTIONS USA, INC.
• eUnity by Client Outlook, Inc.
• CAAS IntraVascular 2.1 by PIE MEDICAL IMAGING B.V.
• 21.3INCH MONOCHROME LCD MONITOR by Nec-Mitsubishi Electric Visual Systems Corp.
• Icobrain by icometrix NV

• Implantable Devices for External Fixation and Related Instruments

  Class IIa

  CE/MDR

• Galaxy Fixation System

  Class I

  CE/MDR

• Truelok/Truelok Plus (Tl/Tl Plus)

  Class I

  CE/MDR

• Orthofix Surgical Instruments

  Class IIa

  CE/MDR

See all devices from Orthofix SRL →