510(k) Report

Devices descending from K111538

18 later devices reach Skaffold Cis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142348OsteoSeal Bone HemostatHemostasis, LLC20150—
+1K141502HBP4 Hardening, Resorbable Hemostatic Bone PuttyOrthocon, Inc.201413—
+1K123243Hemasorb Bone Putty 3 Resorbable Hemostatic Bone PuttyOrthocon, Inc.201316—
+2K242050Montage Settable Bone PuttyOrthocon, Inc.20241—
+2K220315MONTAGE-XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.20221—
+2K202363HBP7 Settable Hemostatic Bone PuttyOrthocon, Inc.20212—
+2K153317HEMASORBPLUS Resorbable Hemostatic Bone PuttyOrthocon, Inc.20160—
+2K152005MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.201512—
+2K143069HEMASORBPLUS press Resorable Hemostatic Bone PuttyOrthocon, Inc.20140—
+3K262769Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)Orthocon, Inc.20260—
+3K261439Permatage Flowable, Settable Hemostatic Bone PasteOrthocon, Inc.20260—
+3K243506Montage-XT Settable Bone PuttyOrthocon, Inc.20240—
+3K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.20233—
+3K191140MONTAGE-QS Settable, Resorbable Hemostatic BoneOrthocon, Inc.20193—
+4K232998Montage- XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.20231—
+4K231903Montage-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+4K193052HBP6 Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc.20201—
+5K231386Montage Flowable XRO Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc.20230—