FDA.report

Distraction plate/rod controller

Definition
A portable, hand-held, electrically-powered device intended to be used to non-invasively and remotely adjust the length of a previously-implanted orthopaedic distraction plate and/or rod (nail); it is not used during the implantation procedure. It is intended to be used with extramedullary distraction plates and/or intramedullary distraction rods to correct long bone fractures and limb length discrepancies, and/or with spinal distraction rods to correct spinal deformities.
GUDID devices
30
Last updated
2020-03-25 20:36:55

Related Product Codes

CodeDeviceSpecialtyClassDevices
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic228
PGNGrowing Rod System- Magnetic ActuationOrthopedic22

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00812258022853PRECICE® Intramedullary Limb Lengthening SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.EAD-M1-0022020-03-10
00812258022860PRECICE® Intramedullary Limb Lengthening SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.EAD-M1-0032020-03-10
00812258022884PRECICE® Intramedullary Limb Lengthening SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.EAD-P2-0112020-03-10
00812258022891PRECICE® Intramedullary Limb Lengthening SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.EAD-P2-0122020-03-10
00812258022907PRECICE® Intramedullary Limb Lengthening SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.EAD-P2-0132020-03-10
00812258026431PRECICE® Intramedullary Limb Lengthening SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.EAD-P1-0202020-03-10
00812258026509PRECICE® Intramedullary Limb Lengthening SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.ERC2P-LAPTOP AR2020-03-10
00812258026516PRECICE® Intramedullary Limb Lengthening SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.ERC2P-LAPTOP EU2020-03-10
00812258026523PRECICE® Intramedullary Limb Lengthening SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.ERC2P-LAPTOP UK2020-03-10
00812258026530PRECICE® Intramedullary Limb Lengthening SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.ERC2P-LAPTOP US2020-03-10
00812258029302PRECICE® Intramedullary Limb Lengthening SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.EAD-P1-0142020-03-10
00856719002008PRECICE® Intramedullary Limb Lengthening SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.EAD-P1-0012020-03-10
00856719002015PRECICE® Intramedullary Limb Lengthening SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.EAD-P1-0022020-03-10
00856719002022PRECICE® Intramedullary Limb Lengthening SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.EAD-P1-0032020-03-10
00856719002046PRECICE® Intramedullary Limb Lengthening SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.EAD-P1-0112020-03-10
00856719002053PRECICE® Intramedullary Limb Lengthening SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.EAD-P1-0122020-03-10
00856719002060PRECICE® Intramedullary Limb Lengthening SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.EAD-P1-0132020-03-10
00856719002206PRECICE® Intramedullary Limb Lengthening SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.EAD-P1-1132020-03-10
00856719002213PRECICE® Intramedullary Limb Lengthening SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.EAD-P1-2132020-03-10
00887517763624PRECICE® Intramedullary Limb Lengthening SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.EAD-M1-0042020-03-10
00812258022839External Remote ControllerNUVASIVE SPECIALIZED ORTHOPEDICS, INC.ERC22015-10-15
00812258022877External Remote ControllerNUVASIVE SPECIALIZED ORTHOPEDICS, INC.ERC2P2015-10-15
00856719002039External Remote ControllerNUVASIVE SPECIALIZED ORTHOPEDICS, INC.P0032015-10-15
00856719002107External Remote ControllerNUVASIVE SPECIALIZED ORTHOPEDICS, INC.P0032015-10-15
00856719002220External Remote ControllerNUVASIVE SPECIALIZED ORTHOPEDICS, INC.P0032015-10-15
00887517001344External Remote ControllerNUVASIVE SPECIALIZED ORTHOPEDICS, INC.ERC-3P2017-12-21
00887517014979External Remote ControllerNUVASIVE SPECIALIZED ORTHOPEDICS, INC.ERC-4P2019-10-15
04260170141651FITBONE®WITTENSTEIN intens GmbHTransmitter2017-12-22
04260170143617FITBONE®WITTENSTEIN intens GmbHCEl 115V2017-12-22
04260170143723FITBONE®WITTENSTEIN intens GmbHCS 115V -A2017-12-22