510(k) Report

Devices descending from K122647

5 later devices reach Synthes Patient Specific Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193280MedCAD® AccuPlate® Patient-Specific PlateMedcad20210—
+1K132519Stryker Customized Mandible Recon Plate KitStryker20133—
+2K193136Stryker Customized Mandible Recon Plate KitStryker20201—
+2K190696Stryker Surgeon iD Mandible Recon PlateStryker20190—
+3K222650Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon PlateStryker Craniomaxillofacial (Cmf)20220—