510(k) Report

Devices descending from K890814

10 later devices reach Danek Ring Fixator (DRF) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071394Modification to:Sbi RingfixSmall Bone Innovations, Inc.200791
+2K253202Hoffmann LRF SystemStryker GmbH20250—
+2K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+2K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+2K093057Biomet Vision Footring SystemEbi, L.P.20095—
+3K253291Excelsior SystemBlue Ocean Global20260—
+3K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+3K140463Integra External Fixation SystemAscension Orthopedic201433
+3K093753Mdpo Frame SystemMdpo, LLC20100—
+4K160830Integra External Fixation SystemAscension Orthopedics201602