510(k) Report

Devices descending from K974309

167 later devices reach Lactosorb Panels through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K113004PDS (TM) Barbed SuturesETHICON, Inc.201111
+6K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare2010241
+6K093408V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare200901
+6K073614WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc.20082—
+7K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—
+7K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™…ETHICON, Inc.20250—
+7K250107V-soft Line™ Barbed Surgical Suture (Various)Feeltech Co., Ltd.20250—
+7K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K240389Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread…Hyundae Meditech Co., Ltd.20241—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K211792StitchKitOrigami Surgical Inc .20211—
+7K200392RexsinSm Eng Co., Ltd.20200—
+7K191361DemeDIOX Barbed Absorbable Surgical SutureDemetech Corporation20190—
+7K190245PDS Barbed Suture, PDO MAXX ThreadsPdo Max, Inc.20190—
+7K182873STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus…ETHICON, Inc.201975
+7K173779Rexmono, PdrexSm Eng Co., Ltd.20180—
+7K162366Omega VLOv World Co., Ltd.20180—
+7K160761DW-1CDongwon Medical Co., Ltd.20161—
+7K151200STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus…ETHICON, Inc.201581
+7K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+7K141778Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corporation201410—
+7K123836Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech201211—
+8K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.20260—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K242571Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150…Hyundae Meditech Co., Ltd.20240—
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K2322461) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2)…M/s. Meril Endo Surgery Private Limited.20241—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K221527StitchKitOrigami Surgical Inc .20230—
+8K221744STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.20222—
+8K212810MONOFIX PGCL, knotless wound closure deviceSamyang Holdings Corp., Ltd.20220—
+8K190437Delta 3300Netech Corporation20190—
+8K143092Tensyn PlugDallen Medical, Inc.20151—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K260038E3D™-C Interbody SystemEvolution Spine20261—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K252644PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™…M/s. Meril Endo Surgery Private Limited.20250—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+9K150359Tensyn PlugDallen Medical, Inc.20150—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—