510(k) Report

Devices descending from K061880

5 later devices reach Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103742Accell EVO3 (Formerly Accell A2I)Integra Life Sciences20110—
+1K091193Accell EVO3CIsotis Orthobiologics, Inc.200921
+1K081817Accell TBM-RIsotis Orthobiologics, Inc.20080—
+2K212135Dry DBM- A PuttySeaspine Corporation20211—
+3K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation20230—