510(k) Report

Devices descending from K111439

345 later devices reach Chesapeake (Cervical Components) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+8K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+8K230026SqualeImplanet, S.A.20230—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+8K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K250769Dakota LP SystemPrecision Spine, Inc.20250—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K252322SIros-X SystemGenesys Spine20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+9K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K223326Axiom PSR SystemRestor3D202301
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—