510(k) Report

Devices descending from K172628

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

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