510(k) Report

Devices descending from K003780

420 later devices reach Vertex Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+9K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+9K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+10K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+10K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K252322SIros-X SystemGenesys Spine20250—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+10K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+10K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+10K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+10K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+11K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—