510(k) Report

Devices descending from K890925

65 later devices reach Manan Bone Marrow Biopsy Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990515Mathis Vertebral and Bone Biopsy SystemInternational Medical Systems199930—
+1K980196MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc.199834Class I
+1K961959MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc.199635—
+2K180807Celling Aspiration NeedleSpine Smith Holdings, LLC20180—
+2K162588Möller Medical Biopsy Needles and SystemsMoller Medical GmbH20171—
+2K062833Powered EZ-IO Bone Marrow Aspiration SystemVidacare Corporation200614—
+2K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft…Sterylab S.R.L.200518—
+2K043523Interv Brand Snarelok Bone Marrow Biopsy NeedleMedical Device Technologies, Inc.200514—
+2K032943Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy KitsStryker Corp.200329—
+3K242128Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall…Xaga Surgical20250—
+3K170008Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle SetCook Incorporated20170—
+3K141673Ivas 8 Gauge Bone Biopsy KitStryker Corporation20140—
+3K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp.201312—
+3K072045Oncontrol Bone Marrow Biopsy SystemVidacare Corporation20077—
+3K071732MarrowminerStemcor Systems, Inc.20074—
+3K070759Powered EZ-IO Pediatric Bone Marrow Aspiration SystemVidacare Corporation20073—
+3K070091Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208Cardinal Health, Inc.20076—
+3K070179Trokabone, Trokabone SternalPAJUNK GmbH Medizintechnologie20070—
+3K060148Ebi Vertebroplasty SystemsEbi, L.P.200618—
+3K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050—
+4K260572Marrow MarxmanMedimetrix, LLC20260—
+4K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+4K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+4K213213Arthrex Vortex Threaded Bone Marrow Recovery NeedleArthrex, Inc.20210—
+4K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,Ranfac Corporation20190—
+4K183146Ranfac Cartilage Biopsy NeedleRanfac Corporation20190—
+4K172558iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy KitStryker Corporation20171—
+4K171531Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow…Care Fusion201736
+4K152474Avitus Bone HarvesterAvitus Orthopaedics, Inc.201531
+4K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp.20154—
+4K141910Intraosseous Cannula System Bio-MAC¿ and Bio-COREBiologic Therapies, Inc.201502
+4K142377The OnControl Bone Marrow Biopsy System by VidacareVidacare, LLC201424
+4K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp.20145—
+4K081713Vertebral Access System by VidacareVidacare Corporation20084—
+4K070527Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek20071—
+4K063248Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek200717—
+5K242322Bone Marrow Biopsy NeedleZhejiang Curaway Medical Technology Co., Ltd.20250—
+5K230015OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power…Laurane Medical Sas20230—
+5K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation20231—
+5K213896BD Trek Powered Bone Biopsy SystemBard Peripheral Vascular20220—
+5K203397Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or…Biopsybell S.R.L.20210—
+5K202287Ran-Flex-B Bone Marrow Aspiration NeedleRanfac Corporation20201—
+5K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone…Medax Srl Unipersonale20200—
+5K180327Stryker iVAS 13g Bone Biopsy KitStryker Corporation20180—
+5K170539Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone…Avitus Orthopaedics, Inc.201721
+5K113452Acu-Cut Vertebral Augmentation SystemAscendx Spine, Inc.20120—
+5K112468The Oncontrol Bone Access System by VidacareRegulatory Specialists, Inc.20113—
+5K072133Avaflex Vertebral Augmentation NeedleCardinal Health, Inc.20073—
+5K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc.200710—
+6K210631Avitus (r) Bone HarvesterAvitus Orthopaedics, Inc.20211—
+6K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—
+6K130402Spider System Kolibri Cement NeedleSintea Plustek, LLC20130—
+6K113872The Oncontrol Bone Access and Bone Biopsy System by VidacareVidacare Corporation201222
+6K100479Parallax Contour Vertebral Augmentation DeviceArthrocare Corp.20101—
+7K243407Forcyte Autograft Harvest KitForcyte Medical, LLC20250—
+7K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+7K181262SpineJack Expansion KitVexim SA20184—
+7K141141Kiva VCF Treatment SystemBenvenue Medical, Inc.20140—
+7K110183Arthrocare Parallax Contour Vertebral Augmentation DeviceArthrocare Corp.20110—
+8K240084V-STRUT® Vertebral ImplantHyprevention20240—
+8K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+8K202393SpineJack Expansion KitStryker Corporation20203—
+9K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+10K223294SpineJack® Expansion KitStryker Instruments20221—
+11K250637VCFix Spinal SystemAmber Implants20250—