510(k) Report

Devices descending from K052494

123 later devices reach Novabone-Bioactive Synthetic Graft through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation20240—
+5K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+5K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+5K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+5K213803FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteProsidyan, Inc.20221—
+5K190814AccuFill Bone Substitute MaterialZimmer Knee Creations20190—
+5K182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc.20180—
+5K182107CarriGen PFEtex Corporation20181—
+5K143547Vivorte Trabexus EBVivorte, Inc.201501
+5K103799Inqu Paste Mix PlusIsto Technologies, Inc.20119—
+5K102528N-Force Fixation SystemInnovision, Inc.20115—
+5K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+6K151146N-Force Fixation SystemInnovision, Inc.20151—
+6K142776Flow-ScrewFlow-Fx, LLC20151—
+6K132244N-Force Fixation SystemInnovision, Inc.20143—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K173556Injection ScrewBiedermann Medtech, Inc.20180—