510(k) Report

Devices descending from K203568

8 later devices reach Hoffmann LRF System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233741Hoffmann LRF SystemStryker GmbH20231—
+1K212895Paragon 28 External Ring Fixation SystemParagon 28, Inc.20215—
+2K253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.20250—
+2K253202Hoffmann LRF SystemStryker GmbH20250—
+2K232838Monkey RingsTM External Fixation SystemParagon 28, Inc.20233—
+3K253291Excelsior SystemBlue Ocean Global20260—
+3K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+4K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—