MIS Golden Isles Pedicle Screw System

GUDID G079C50800000220

K-wire 45mm screw Standard Driver

Intelivation, LLC

Orthopaedic bone wire

• Primary Device ID: G079C50800000220
• NIH Device Record Key: b66dcfe2-dc3c-4715-91b5-6d05fe76a008
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIS Golden Isles Pedicle Screw System
• Version Model Number: C50-8000-022
• 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: true
• 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: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com
• Phone: 9124342780
• Email: contact@intelivationtech.com

Device Dimensions

• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G079C50800000220 [Primary]

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[G079C50800000220]

Moist Heat or Steam Sterilization

[G079C50800000220]

Moist Heat or Steam Sterilization

[G079C50800000220]

Moist Heat or Steam Sterilization

[G079C50800000220]

Moist Heat or Steam Sterilization

[G079C50800000220]

Moist Heat or Steam Sterilization

[G079C50800000220]

Moist Heat or Steam Sterilization

[G079C50800000220]

Moist Heat or Steam Sterilization

[G079C50800000220]

Moist Heat or Steam Sterilization

[G079C50800000220]

Moist Heat or Steam Sterilization

[G079C50800000220]

Moist Heat or Steam Sterilization

[G079C50800000220]

Moist Heat or Steam Sterilization

[G079C50800000220]

Moist Heat or Steam Sterilization

[G079C50800000220]

Moist Heat or Steam Sterilization

[G079C50800000220]

Moist Heat or Steam Sterilization

[G079C50800000220]

Moist Heat or Steam Sterilization

[G079C50800000220]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-05
• Device Publish Date: 2023-06-27

On-Brand Devices [MIS Golden Isles Pedicle Screw System ]

• G079C511000A020: MIS Reduction Headbody
• G079C510000A030: MIS Extended Tab
• G079C25200A300: Ø5.5mm MIS Curved Rod, 30mm
• G079C25200A2500: Ø5.5mm MIS Curved Rod, 250mm
• G079C25200A2400: Ø5.5mm MIS Curved Rod, 240mm
• G079C25200A2300: Ø5.5mm MIS Curved Rod, 230mm
• G079C25200A2200: Ø5.5mm MIS Curved Rod, 220mm
• G079C25200A2100: Ø5.5mm MIS Curved Rod, 210mm
• G079C25200A2000: Ø5.5mm MIS Curved Rod, 200mm
• G079C25200A1900: Ø5.5mm MIS Curved Rod, 190mm
• G079C25200A1800: Ø5.5mm MIS Curved Rod, 180mm
• G079C25200A1700: Ø5.5mm MIS Curved Rod, 170mm
• G079C25200A1600: Ø5.5mm MIS Curved Rod, 160mm
• G079C25200A1500: Ø5.5mm MIS Curved Rod, 150mm
• G079C25200A1400: Ø5.5mm MIS Curved Rod, 140mm
• G079C25200A1300: Ø5.5mm MIS Curved Rod, 130mm
• G079C25200A1200: Ø5.5mm MIS Curved Rod, 120mm
• G079C25200A1100: Ø5.5mm MIS Curved Rod, 110mm
• G079C25200A1000: Ø5.5mm MIS Curved Rod, 100mm
• G079C25200A0950: Ø5.5mm MIS Curved Rod, 95mm
• G079C25200A0900: Ø5.5mm MIS Curved Rod, 90mm
• G079C25200A0850: Ø5.5mm MIS Curved Rod, 85mm
• G079C25200A0800: Ø5.5mm MIS Curved Rod, 80mm
• G079C25200A0750: Ø5.5mm MIS Curved Rod, 75mm
• G079C25200A0700: Ø5.5mm MIS Curved Rod, 70mm
• G079C25200A0650: Ø5.5mm MIS Curved Rod, 65mm
• G079C25200A0600: Ø5.5mm MIS Curved Rod, 60mm
• G079C25200A0550: Ø5.5mm MIS Curved Rod, 55mm
• G079C25200A0500: Ø5.5mm MIS Curved Rod, 50mm
• G079C25200A0450: Ø5.5mm MIS Curved Rod, 45mm
• G079C25200A0400: Ø5.5mm MIS Curved Rod, 40mm
• G079C25200A0350: Ø5.5mm MIS Curved Rod, 35mm
• G070C511000A010: MIS Standard Headbody
• G079C50800000220: K-wire 45mm screw Standard Driver
• G079CC5080000010: Modified MIS Driver
• G079CC5030000090: Modified Reduction Driver
• G079C5080000210: Impaction Cap
• G079C5080000200: Shorter Driver
• G079C5080000160: Set Screw Shaft C/D
• G079C5080000110: MIS Rod Holder
• G079C5080000090: Screw Depth Measuring Instrument
• G079C5080000080: MIS Tab Breaker
• G079C5080000070: MIS Counter Torque Proximal
• G079C5080000060: Rod Indicator
• G079C5080000050: MIS Counter Torque Distal
• G079C5080000040: MIS Final Tightener shaft
• G079C5080000030: MIS Provisional Locking Cap Driver
• G079C5080000020: MIS Tab Inserter
• G079C5080000010: MIS Driver
• G079C500000A02C0: GI MIS Screw Caddy