510(k) Report

Devices descending from K051739

427 later devices reach Pocket Transcranial and Vascular Doppler Spectrum Analyzer, Model 500P; PW… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+9K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+9K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+9K210549ARx Spinal SystemLife Spine, Inc.20211—
+9K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+10K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+10K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+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—
+10K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+10K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+10K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+10K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+11K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+11K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+11K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+12K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—