icotec Pedicle System, Cross-Link, Ti, 40/53 mm 16-57-94053

GUDID 07640164846293

icotec Pedicle System, Cross-Link, Ti, 40/53 mm

icotec AG

Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 07640164846293
• NIH Device Record Key: 86a747df-a94d-4193-9dc4-566982e25db3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: icotec Pedicle System, Cross-Link, Ti, 40/53 mm
• Version Model Number: 16-57-94053
• Catalog Number: 16-57-94053
• Company DUNS: 480789465
• Company Name: icotec AG
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch
• Phone: +41717570000
• Email: info@icotec.ch

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640164846293 [Primary]

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-12-23
• Device Publish Date: 2019-08-23

Devices Manufactured by icotec AG

• 07640164846675 - VADER Pedicle System MIS, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 30 mm: 2024-04-04 VADER Pedicle System MIS, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 30 mm
• 07640164846804 - VADER Pedicle System MIS, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 30 mm: 2024-04-04 VADER Pedicle System MIS, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 30 mm
• 07640164846880 - VADER Pedicle System MIS, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 30 mm: 2024-04-04 VADER Pedicle System MIS, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 30 mm
• 07640164848785 - icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 35 mm: 2024-04-04 icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 35 mm
• 07640164848792 - icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 40 mm: 2024-04-04 icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 40 mm
• 07640164848808 - icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 45 mm: 2024-04-04 icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 45 mm
• 07640164848815 - icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 50 mm: 2024-04-04 icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 50 mm
• 07640164848822 - icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 55 mm: 2024-04-04 icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 55 mm