510(k) Report

Devices descending from K082491

28 later devices reach Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153095ROP Resorbable Hemostasis MaterialResorbable Orthopedic Products, LLC20160—
+1K113079Synthes Hemostatic Bone PuttySynthes (Usa) Products, LLC/Norian Corporation20115Class I
+1K103822Synthes Hemostatic Bone Putty (HBP)Synthes USA Products, LLC20110Class I
+1K091636Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc.200920—
+2K142348OsteoSeal Bone HemostatHemostasis, LLC20150—
+2K122156Orthocon Absorbable Hemostatic Bone PuttyOrthocon, Inc.20133—
+2K111524MP 719Marine Polymer Technologies, Inc.20110—
+2K103047Ceretene Soluble Implant MaterialCeremed, Inc.20110—
+2K102071Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc.201017—
+3K141502HBP4 Hardening, Resorbable Hemostatic Bone PuttyOrthocon, Inc.201413—
+3K140117Ahbppress Absorbable Hemostatic Bone PuttyOrthocon, Inc.20142—
+3K111575Hemasorb Absorbable Bone Hemostat MatrixOrthocon, Inc.20126—
+4K242050Montage Settable Bone PuttyOrthocon, Inc.20241—
+4K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.20233—
+4K220315MONTAGE-XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.20221—
+4K202363HBP7 Settable Hemostatic Bone PuttyOrthocon, Inc.20212—
+4K152005MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.201512—
+4K143069HEMASORBPLUS press Resorable Hemostatic Bone PuttyOrthocon, Inc.20140—
+4K142339HEMASORB Resorbable Hemostatic Bone PuttyOrthocon, LLC20140—
+4K121953Hemasorb ApplyOrthocon, Inc.20120—
+5K262769Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)Orthocon, Inc.20260—
+5K261439Permatage Flowable, Settable Hemostatic Bone PasteOrthocon, Inc.20260—
+5K243506Montage-XT Settable Bone PuttyOrthocon, Inc.20240—
+5K232998Montage- XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.20231—
+5K191140MONTAGE-QS Settable, Resorbable Hemostatic BoneOrthocon, Inc.20193—
+6K231903Montage-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+6K193052HBP6 Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc.20201—
+7K231386Montage Flowable XRO Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc.20230—