VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 40 mm 16-6022-54540

GUDID 07640172551561

VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 40 mm

icotec AG

Spinal bone screw, non-bioabsorbable
Primary Device ID07640172551561
NIH Device Record Keyb606f631-add4-4a60-8eef-fddf9f5bae54
Commercial Distribution StatusIn Commercial Distribution
Brand NameVADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 40 mm
Version Model Number16-6022-54540
Catalog Number16-6022-54540
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
GS107640172551561 [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

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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
07640172552612 - CMORE® System, Palm Handle, AO Coupling2025-12-02 CMORE® System, Palm Handle, AO Coupling

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