510(k) Report

Devices descending from K180179

37 later devices reach Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+1K231658VEOS Spinal Fixation SystemSpineway20230—
+1K223273ASTRA Spine SystemSpinecraft, LLC20228—
+1K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+1K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+1K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+1K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+1K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+1K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+1K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+1K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+1K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+2K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+2K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+2K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+2K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+2K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+2K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+2K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+2K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+2K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+2K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+2K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+2K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+2K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+2K220025ARx® Spinal SystemLife Spine, Inc.20220—
+2K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+3K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+3K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+3K252322SIros-X SystemGenesys Spine20250—
+3K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+3K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—