Golden Isles Pedicle Screw System

GUDID G079C5010000010

Jamshidi

Intelivation, LLC

Orthopaedic feeler Orthopaedic feeler Orthopaedic feeler Orthopaedic feeler Orthopaedic feeler Orthopaedic feeler Orthopaedic feeler Orthopaedic feeler Orthopaedic feeler Orthopaedic feeler Orthopaedic feeler Orthopaedic feeler Orthopaedic feeler Orthopaedic feeler Orthopaedic feeler

• Primary Device ID: G079C5010000010
• NIH Device Record Key: a5a4c157-ae5a-4ee3-8ef3-69c0750126d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Golden Isles Pedicle Screw System
• Version Model Number: C50-1000-001
• Company DUNS: 037368183
• Company Name: Intelivation, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: (912) 434-2780
• Email: contact@intelivationtech.com
• Phone: (912) 434-2780
• Email: contact@intelivationtech.com
• Phone: (912) 434-2780
• Email: contact@intelivationtech.com
• Phone: (912) 434-2780
• Email: contact@intelivationtech.com
• Phone: (912) 434-2780
• Email: contact@intelivationtech.com
• Phone: (912) 434-2780
• Email: contact@intelivationtech.com
• Phone: (912) 434-2780
• Email: contact@intelivationtech.com
• Phone: (912) 434-2780
• Email: contact@intelivationtech.com
• Phone: (912) 434-2780
• Email: contact@intelivationtech.com
• Phone: (912) 434-2780
• Email: contact@intelivationtech.com
• Phone: (912) 434-2780
• Email: contact@intelivationtech.com
• Phone: (912) 434-2780
• Email: contact@intelivationtech.com
• Phone: (912) 434-2780
• Email: contact@intelivationtech.com
• Phone: (912) 434-2780
• Email: contact@intelivationtech.com
• Phone: (912) 434-2780
• Email: contact@intelivationtech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G079C5010000010 [Primary]

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[G079C5010000010]

Moist Heat or Steam Sterilization

[G079C5010000010]

Moist Heat or Steam Sterilization

[G079C5010000010]

Moist Heat or Steam Sterilization

[G079C5010000010]

Moist Heat or Steam Sterilization

[G079C5010000010]

Moist Heat or Steam Sterilization

[G079C5010000010]

Moist Heat or Steam Sterilization

[G079C5010000010]

Moist Heat or Steam Sterilization

[G079C5010000010]

Moist Heat or Steam Sterilization

[G079C5010000010]

Moist Heat or Steam Sterilization

[G079C5010000010]

Moist Heat or Steam Sterilization

[G079C5010000010]

Moist Heat or Steam Sterilization

[G079C5010000010]

Moist Heat or Steam Sterilization

[G079C5010000010]

Moist Heat or Steam Sterilization

[G079C5010000010]

Moist Heat or Steam Sterilization

[G079C5010000010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-03
• Device Publish Date: 2022-10-26

On-Brand Devices [Golden Isles Pedicle Screw System]

• G079C6050005640: K-Wire Driver
• G079C5121851100: Ø8.5mm Dual Lead Cannulated Screw
• G079C5121851000: Ø8.5mm Dual Lead Cannulated Screw
• G079C5121850900: Ø8.5mm Dual Lead Cannulated Screw
• G079C5121850800: Ø8.5mm Dual Lead Cannulated Screw
• G079C5121850700: Ø8.5mm Dual Lead Cannulated Screw
• G079C5121850600: Ø8.5mm Dual Lead Cannulated Screw
• G079C5121850550: Ø8.5mm Dual Lead Cannulated Screw
• G079C5121850500: Ø8.5mm Dual Lead Cannulated Screw
• G079C5121850450: Ø8.5mm Dual Lead Cannulated Screw
• G079C5121850400: Ø8.5mm Dual Lead Cannulated Screw
• G079C5121850350: Ø8.5mm Dual Lead Cannulated Screw
• G079C5121850300: Ø8.5mm Dual Lead Cannulated Screw
• G079C5121850250: Ø8.5mm Dual Lead Cannulated Screw
• G079C5121751100: Ø7.5mm Dual Lead Cannulated Screw
• G079C5121751000: Ø7.5mm Dual Lead Cannulated Screw
• G079C5121750900: Ø7.5mm Dual Lead Cannulated Screw
• G079C5121750800: Ø7.5mm Dual Lead Cannulated Screw
• G079C5121750700: Ø7.5mm Dual Lead Cannulated Screw
• G079C5121750600: Ø7.5mm Dual Lead Cannulated Screw
• G079C5121750550: Ø7.5mm Dual Lead Cannulated Screw
• G079C5121750500: Ø7.5mm Dual Lead Cannulated Screw
• G079C5121750450: Ø7.5mm Dual Lead Cannulated Screw
• G079C5121750400: Ø7.5mm Dual Lead Cannulated Screw
• G079C5121750350: Ø7.5mm Dual Lead Cannulated Screw
• G079C5121750300: Ø7.5mm Dual Lead Cannulated Screw
• G079C5121750250: Ø7.5mm Dual Lead Cannulated Screw
• G079C5121650600: Ø6.5mm Dual Lead Cannulated Screw
• G079C5121650550: Ø6.5mm Dual Lead Cannulated Screw
• G079C5121650500: Ø6.5mm Dual Lead Cannulated Screw
• G079C5121650450: Ø6.5mm Dual Lead Cannulated Screw
• G079C5121650400: Ø6.5mm Dual Lead Cannulated Screw
• G079C5121650350: Ø6.5mm Dual Lead Cannulated Screw
• G079C5121650300: Ø6.5mm Dual Lead Cannulated Screw
• G079C5121650250: Ø6.5mm Dual Lead Cannulated Screw
• G079C5121550600: Ø5.5mm Dual Lead Cannulated Screw
• G079C5121550550: Ø5.5mm Dual Lead Cannulated Screw
• G079C5121550500: Ø5.5mm Dual Lead Cannulated Screw
• G079C5121550450: Ø5.5mm Dual Lead Cannulated Screw
• G079C5121550400: Ø5.5mm Dual Lead Cannulated Screw
• G079C5121550350: Ø5.5mm Dual Lead Cannulated Screw
• G079C5121550300: Ø5.5mm Dual Lead Cannulated Screw
• G079C5121550250: Ø5.5mm Dual Lead Cannulated Screw
• G079C5120851100: Ø8.5mm Dual Lead Screw
• G079C5120851000: Ø8.5mm Dual Lead Screw
• G079C5120850900: Ø8.5mm Dual Lead Screw
• G079C5120850800: Ø8.5mm Dual Lead Screw
• G079C5120850700: Ø8.5mm Dual Lead Screw
• G079C5120850600: Ø8.5mm Dual Lead Screw
• G079C5120850550: Ø8.5mm Dual Lead Screw