510(k) Report

Devices descending from K874684

428 later devices reach TC2-64B Transcranial Doppler through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K240368E3D™-A Interbody SystemEvolution Spine20247—
+10K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+10K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+10K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+10K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+10K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+10K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+10K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+10K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+10K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+10K210549ARx Spinal SystemLife Spine, Inc.20211—
+10K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+11K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+11K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+11K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+11K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+11K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+11K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+11K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+11K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+11K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+11K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+11K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+12K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+12K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+12K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+13K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—