510(k) Report

Devices descending from K043346

2 later devices reach Genesis Total Shoulder Replacement, Model 100-01-00 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+1K120374Seviin Reverse ShoulderIngen Orthopedics, LLC20121—