510(k) Report

Devices descending from K181827

6 later devices reach Affixus Natural Nail System Humeral Nail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH20250—
+1K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH20234—
+1K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH20201—
+2K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.2024217
+3K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+3K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250—