510(k) Report

Devices descending from K802814

14 later devices reach Orthofix Axialexternal Fixation Sys. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023714Reprocessed External Fixation DeviceAlliance Medical Corp.20031—
+1K970751Heidelberg External FixatorSmith & Nephew, Inc., Orthopaedic Div.199711—
+2K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+2K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+2K090926Smith & Nephew Rail SystemSmith & Nephew, Inc.200910—
+2K052065Alliance Medical Corporation Reprocessed External Fixation DevicesAlliance Medical Corp.20050—
+3K253291Excelsior SystemBlue Ocean Global20260—
+3K253202Hoffmann LRF SystemStryker GmbH20250—
+3K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+3K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+3K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+3K200518Pitkar External Fixation System - Rail MechanismS.H.Pitkar Orthotools Pvt., Ltd.20202—
+4K241357XT3 SystemBiodynamik, Inc.20251—
+5K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—