VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 35 mm 16-6022-54535

GUDID 07640172551554

VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 35 mm

icotec AG

Spinal bone screw, non-bioabsorbable
Primary Device ID07640172551554
NIH Device Record Key5b46aac1-d24e-4151-ad4b-eb7424f8501d
Commercial Distribution StatusIn Commercial Distribution
Brand NameVADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 35 mm
Version Model Number16-6022-54535
Catalog Number16-6022-54535
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
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
GS107640172551554 [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

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
07640172552001 - VADER Pedicle System, Template for HT S-rods2025-08-07 VADER Pedicle System, Template for HT S-rods
07640172552018 - VADER Pedicle System, Template for TL S-rods2025-08-07 VADER Pedicle System, Template for TL S-rods
07640172552025 - VADER Pedicle System, Template for L S-rods2025-08-07 VADER Pedicle System, Template for L S-rods
07640172552056 - VADER Pedicle System, Template for R120 & R450 curved rods2025-08-07 VADER Pedicle System, Template for R120 & R450 curved rods
07640172552063 - VADER Pedicle System, Hexagon screw driver2025-08-07 VADER Pedicle System, Hexagon screw driver

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.