510(k) Report

Devices descending from K001132

22 later devices reach Bone Biopsy Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080095Coramate/Spirotome SystemMedinvents200811
+1K050795Imbibe Bone Marrow Aspiration NeedleOrthovita, Inc.200519—
+2K190378Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome…Bioncise NV20190—
+2K143546Imbibe Aspirating XIA TapsStryker Corporation20150—
+2K140868Stryker Kwic NeedleOrthovita, Inc.20141—
+2K140414Imbibe NeedleOrthovita, Inc.201411
+2K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp.201312—
+2K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050—
+3K260572Marrow MarxmanMedimetrix, LLC20260—
+3K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+3K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+3K213213Arthrex Vortex Threaded Bone Marrow Recovery NeedleArthrex, Inc.20210—
+3K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+3K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,Ranfac Corporation20190—
+3K183146Ranfac Cartilage Biopsy NeedleRanfac Corporation20190—
+3K180807Celling Aspiration NeedleSpine Smith Holdings, LLC20180—
+3K153306Imbibe NeedleOrthovita, Inc.20150—
+3K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp.20154—
+3K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp.20145—
+4K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation20231—
+4K203397Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or…Biopsybell S.R.L.20210—
+4K202287Ran-Flex-B Bone Marrow Aspiration NeedleRanfac Corporation20201—