510(k) Report

Devices descending from K172061

17 later devices reach PRECICE UNYTE System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172628PRECICE SystemNuvasive Specialized Orthopedics, Inc.201716—
+2K220234Precice Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc.20233—
+2K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+2K173129PRECICE SystemNuvasive Specialized Orthopedics, Inc.201713—
+3K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics20260—
+3K232267Precice Max SystemNuvasive Specialized Orthopedics, Incorporated202311
+3K230765Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc.20231—
+3K191336PRECICE SystemNuvasive Specialized Orthopedics, Inc.20191—
+3K182170PRECICE® BONE TRANSPORT™ SystemNuvasive Specialized Orthopedics, Inc.201961
+3K180503PRECICE STRYDE SystemNuvasive Specialized Orthopedics, Inc.2018121
+4K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+4K200430Precice® Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc.20203—
+4K193016PRECICE Bone Transport SystemNuvasive Specialized Orthopedics, Inc.202041
+5K201567Precice® Bone Transport SystemNuvasive Specialized Orthopedics, Inc.202032
+6K232169FITBONE® Transport and Lengthening SystemOrthofix Srl20242—
+7K260146Fitbone® Transport and Lengthening SystemOrthofix Srl20260—
+7K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAOrthofix Srl20260—