Golden Isles Pedicle Screw System C508000028

GUDID G079C5080000280

MIS Driver Long

Intelivation, LLC

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: G079C5080000280
• NIH Device Record Key: 1025e587-6cde-4fb2-b487-c7ed03a3eb73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Golden Isles Pedicle Screw System
• Version Model Number: C50-8000-028
• Catalog Number: C508000028
• Company DUNS: 037368183
• Company Name: Intelivation, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G079C5080000280 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[G079C5080000280]

Moist Heat or Steam Sterilization

[G079C5080000280]

Moist Heat or Steam Sterilization

[G079C5080000280]

Moist Heat or Steam Sterilization

[G079C5080000280]

Moist Heat or Steam Sterilization

[G079C5080000280]

Moist Heat or Steam Sterilization

[G079C5080000280]

Moist Heat or Steam Sterilization

[G079C5080000280]

Moist Heat or Steam Sterilization

[G079C5080000280]

Moist Heat or Steam Sterilization

[G079C5080000280]

Moist Heat or Steam Sterilization

[G079C5080000280]

Moist Heat or Steam Sterilization

[G079C5080000280]

Moist Heat or Steam Sterilization

[G079C5080000280]

Moist Heat or Steam Sterilization

[G079C5080000280]

Moist Heat or Steam Sterilization

[G079C5080000280]

Moist Heat or Steam Sterilization

[G079C5080000280]

Moist Heat or Steam Sterilization

[G079C5080000280]

Moist Heat or Steam Sterilization

[G079C5080000280]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-19
• Device Publish Date: 2024-11-11

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