510(k) Report

Devices descending from K043578

125 later devices reach The 4CIS Spinal System and 4CIS Low Back System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+8K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+8K210549ARx Spinal SystemLife Spine, Inc.20211—
+8K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+9K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+10K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+10K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+10K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—