510(k) Report

Devices descending from K020699

636 later devices reach TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K240526POWEReam Xia/SerratoStryker Instruments20240—
+6K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K221244CD Horizon™ Spinal SystemMedtronic202220—
+6K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+6K210637CD Horizon™ Spinal SystemMedtronic202134—
+6K202771CD Horizon Spinal SystemMedtronic202021—
+6K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+6K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K190376PASS LP Spinal SystemMedicrea International SA201915
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+6K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+6K180376K2M Patient Specific RodsK2m, Inc.20182—
+6K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+6K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+6K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+6K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+6K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+6K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+6K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+6K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+6K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+6K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+6K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+6K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+6K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+6K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+6K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+6K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+6K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+6K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+6K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+6K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+6K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+6K122592Instinct Java SystemZimmer Spine201301
+6K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+6K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+6K121630Range Spinal SystemK2m, Inc.2012127—
+6K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+6K120564Calypso SystemHogan Lovells US LLP201216—
+6K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+7K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+7K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+7K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—
+7K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+7K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+7K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+7K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+7K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+7K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+7K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—