VADER Pedicle System, Template for R120 & R450 curved rods 42-897

GUDID 07640172552056

VADER Pedicle System, Template for R120 & R450 curved rods

icotec AG

Surgical implant template, reusable
Primary Device ID07640172552056
NIH Device Record Key7f121ad5-4eb9-487f-89ce-54a4951e9787
Commercial Distribution StatusIn Commercial Distribution
Brand NameVADER Pedicle System, Template for R120 & R450 curved rods
Version Model Number42-897
Catalog Number42-897
Company DUNS480789465
Company Nameicotec AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch
Phone+41717570000
Emailinfo@icotec.ch

Device Identifiers

Device Issuing AgencyDevice ID
GS107640172552056 [Primary]

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640172552056]

Moist Heat or Steam Sterilization


[07640172552056]

Moist Heat or Steam Sterilization


[07640172552056]

Moist Heat or Steam Sterilization


[07640172552056]

Moist Heat or Steam Sterilization


[07640172552056]

Moist Heat or Steam Sterilization


[07640172552056]

Moist Heat or Steam Sterilization


[07640172552056]

Moist Heat or Steam Sterilization


[07640172552056]

Moist Heat or Steam Sterilization


[07640172552056]

Moist Heat or Steam Sterilization


[07640172552056]

Moist Heat or Steam Sterilization


[07640172552056]

Moist Heat or Steam Sterilization


[07640172552056]

Moist Heat or Steam Sterilization


[07640172552056]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-08-07
Device Publish Date2023-01-13

Devices Manufactured by icotec AG

07640172553848 - icotec Systems, Handle, 1/4" Coupling2025-08-21 icotec Systems, Handle, 1/4" Coupling
07640172553855 - icotec Systems, Fixation device2025-08-21 icotec Systems, Fixation device
07640172553862 - icotec Systems, Deburring tool2025-08-21 icotec Systems, Deburring tool
07640172553879 - icotec Systems, Handle for deburrer, M62025-08-21 icotec Systems, Handle for deburrer, M6
07640172553831 - icotec Systems, Navigation Adapter2025-08-20 icotec Systems, Navigation Adapter
07640172551967 - VADER Pedicle System, Handle, 1/4" Coupling2025-08-07 VADER Pedicle System, Handle, 1/4" Coupling
07640172551981 - VADER Pedicle System, Deburring tool2025-08-07 VADER Pedicle System, Deburring tool
07640172551998 - VADER Pedicle System, Trial rod, flexible, Ø 5.5 mm; L = 300 mm2025-08-07 VADER Pedicle System, Trial rod, flexible, Ø 5.5 mm; L = 300 mm

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