VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 6.5 x 55 mm 16-6023-56555

GUDID 07640164849225

VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 6.5 x 55 mm

icotec AG

Bone-screw internal spinal fixation system, sterile
Primary Device ID07640164849225
NIH Device Record Keya8940af6-7940-41e5-99f4-f03b026229e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameVADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 6.5 x 55 mm
Version Model Number16-6023-56555
Catalog Number16-6023-56555
Company DUNS480789465
Company Nameicotec AG
Device Count1
DM Exempttrue
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
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
GS107640164849225 [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 Date2024-04-04
Device Publish Date2019-08-23

Devices Manufactured by icotec AG

07640172553916 - KONG-TL VBR System, Guiding Sleeve for locking screwdriver2026-02-06 KONG-TL VBR System, Guiding Sleeve for locking screwdriver
07640172552544 - CMORE® System, Awl2025-12-02 CMORE® System, Awl
07640172552551 - CMORE® System, Pedicle Probe, Straight2025-12-02 CMORE® System, Pedicle Probe, Straight
07640172552568 - CMORE® System, Drill Guide Sleeve2025-12-02 CMORE® System, Drill Guide Sleeve
07640172552575 - CMORE® System, Drill Guide Stop2025-12-02 CMORE® System, Drill Guide Stop
07640172552582 - CMORE® System, Drill Bit, Ø 2.3 mm2025-12-02 CMORE® System, Drill Bit, Ø 2.3 mm
07640172552599 - CMORE® System, Feeler2025-12-02 CMORE® System, Feeler
07640172552605 - CMORE® System, In-line Handle, AO Coupling2025-12-02 CMORE® System, In-line Handle, AO Coupling

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.