510(k) Report

Devices descending from K003397

5 later devices reach Colles C Series Frame Sterile Pack through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012294Wristore FixatorMillennium Medical Technologies, Inc.20023—
+1K013503Modification to: Sterile Colles Classic FixatorDePuy Orthopaedics, Inc.200101
+2K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+2K042761Wristore Distal Radius Fracture Fixator, 4600 SeriesZimmer, Inc.20041—
+3K052498Fragment Specific FixatorDavid J. Slutsky MD20050—