510(k) Report

Devices descending from K061202

547 later devices reach Revere Stabilization System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+7K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+7K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+7K211306LabyrinthZavation Medical Products, LLC20213—
+7K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+7K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+7K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+7K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+7K193219G Surgical Marksman SystemG Surgical, LLC20191—
+7K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+7K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+7K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+7K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+8K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+8K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+8K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+8K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+8K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+8K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+8K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+8K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+8K203452Nano FortiFix® SystemNanovis, LLC20200—
+8K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K250769Dakota LP SystemPrecision Spine, Inc.20250—
+9K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+9K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K230329F3D Interbody SystemCorelink, LLC20230—
+10K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+11K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—