VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 050 mm 16-60-21205

GUDID 07640172551776

VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 050 mm

icotec AG

Bone-screw internal spinal fixation system rod
Primary Device ID07640172551776
NIH Device Record Keyd891fa06-5dc5-421e-a9cd-34963c5277b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameVADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 050 mm
Version Model Number16-60-21205
Catalog Number16-60-21205
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107640172551776 [Primary]

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-08-08
Device Publish Date2023-01-12

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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