510(k) Report

Devices descending from K210482

4 later devices reach Medline UNITE REFLEX Nitinol Staple System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250712Linkt Compression Staple SystemTrax Surgical20250—
+1K232905Medline UNITE® REFLEX® Nitinol Staple KitMedline Industries, LP20230—
+1K231885Medline UNITE® REFLEX® Nitinol Staple SystemMedline Industries, LP20233—
+2K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—