VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 30 mm 16-6022-54530

GUDID 07640172551547

VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 30 mm

icotec AG

Spinal bone screw, non-bioabsorbable
Primary Device ID07640172551547
NIH Device Record Key5478a89b-5a8f-4c0e-8a8c-503b4fe42e77
Commercial Distribution StatusIn Commercial Distribution
Brand NameVADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 30 mm
Version Model Number16-6022-54530
Catalog Number16-6022-54530
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
GS107640172551547 [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

07640172551530 - VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 25 mm2024-08-08 VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 25 mm
07640172551547 - VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 30 mm2024-08-08VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 30 mm
07640172551547 - VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 30 mm2024-08-08 VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 30 mm
07640172551554 - VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 35 mm2024-08-08 VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 35 mm
07640172551561 - VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 40 mm2024-08-08 VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 40 mm
07640172551578 - VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 45 mm2024-08-08 VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 45 mm
07640172551585 - VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 50 mm2024-08-08 VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 50 mm
07640172551615 - VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 040 mm2024-08-08 VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 040 mm
07640172551622 - VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 050 mm2024-08-08 VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 050 mm

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