510(k) Report

Devices descending from K133494

330 later devices reach Chesapeake Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K250769Dakota LP SystemPrecision Spine, Inc.20250—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K252322SIros-X SystemGenesys Spine20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+8K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223326Axiom PSR SystemRestor3D202301
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—