510(k) Report

Devices descending from K960978

320 later devices reach Wright Plaster of Paris Pellets (Subject to Revision) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K082463ProgenixMedtronic Sofamor Danek20080—
+7K081950Progenix PlusMedtronic Sofamor Danek, Inc.20081—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation20240—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K190814AccuFill Bone Substitute MaterialZimmer Knee Creations20190—
+8K182107CarriGen PFEtex Corporation20181—
+8K143547Vivorte Trabexus EBVivorte, Inc.201501
+8K102528N-Force Fixation SystemInnovision, Inc.20115—
+8K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+9K151146N-Force Fixation SystemInnovision, Inc.20151—
+9K142776Flow-ScrewFlow-Fx, LLC20151—
+9K132244N-Force Fixation SystemInnovision, Inc.20143—
+10K173556Injection ScrewBiedermann Medtech, Inc.20180—