510(k) Report

Devices descending from K043565

834 later devices reach Modification to Dynesys Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K172194Connector SystemOrthofix, Inc.2017162
+10K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+11K261279DeltaNEC Interbody SystemNexus Spine20260—
+11K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+11K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+11K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+11K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+11K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+11K250637VCFix Spinal SystemAmber Implants20250—
+11K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+11K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+11K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+11K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+11K240699SCARLET® AC-TiSpineart SA20240—
+11K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+11K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+11K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+11K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+11K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+11K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+11K223326Axiom PSR SystemRestor3D202301
+11K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+11K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+11K190751Connector SystemOrthofix, Inc.20193—
+11K182182YUKON OCT Spinal SystemK2m20185—
+11K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+12K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+12K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+12K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+12K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+12K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+12K193129Yukon OCT Spinal SystemK2m, Inc.202001