510(k) Report

Devices descending from K083071

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+7K190751Connector SystemOrthofix, Inc.20193—
+7K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+8K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+9K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K252322SIros-X SystemGenesys Spine20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+9K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+10K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—