KHEIRON 24BR55105

GUDID 03701313001803

Ø5.5 L105mm pre bent Ti rod

S.M.A.I.O

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 03701313001803
• NIH Device Record Key: 0c33b11c-524f-4a81-b603-ddb31707bbc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KHEIRON
• Version Model Number: 24BR55105
• Catalog Number: 24BR55105
• Company DUNS: 260585710
• Company Name: S.M.A.I.O
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com
• Phone: +33469842302
• Email: contact@smaio.com

Device Dimensions

• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701313001803 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201659

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

[03701313001803]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-22
• Device Publish Date: 2020-12-14

On-Brand Devices [KHEIRON]

• 03701313001230: Ø8.5 L60mm pedicle screw
• 03701313001223: Ø8.5 L55mm pedicle screw
• 03701313001216: Ø8.5 L50mm pedicle screw
• 03701313001209: Ø8.5 L45mm pedicle screw
• 03701313001193: Ø8.5 L40mm pedicle screw
• 03701313001186: Ø8.5 L35mm pedicle screw
• 03701313001179: Ø8.5 L30mm pedicle screw
• 03701313001162: Ø8.5 L25mm pedicle screw
• 03701313001087: Ø7.5 L60mm pedicle screw
• 03701313001070: Ø7.5 L55mm pedicle screw
• 03701313001063: Ø7.5 L50mm pedicle screw
• 03701313001056: Ø7.5 L45mm pedicle screw
• 03701313001049: Ø7.5 L40mm pedicle screw
• 03701313001032: Ø7.5 L35mm pedicle screw
• 03701313001025: Ø7.5 L30mm pedicle screw
• 03701313001018: Ø7.5 L25mm pedicle screw
• 03701313000998: Ø6.5 L60mm pedicle screw
• 03701313000981: Ø6.5 L55mm pedicle screw
• 03701313000974: Ø6.5 L50mm pedicle screw
• 03701313000967: Ø6.5 L45mm pedicle screw
• 03701313000950: Ø6.5 L40mm pedicle screw
• 03701313000943: Ø6.5 L35mm pedicle screw
• 03701313000936: Ø6.5 L30mm pedicle screw
• 03701313000929: Ø6.5 L25mm pedicle screw
• 03701313000905: Ø5.5 L60mm pedicle screw
• 03701313000899: Ø5.5 L55mm pedicle screw
• 03701313000882: Ø5.5 L50mm pedicle screw
• 03701313000875: Ø5.5 L45mm pedicle screw
• 03701313000868: Ø5.5 L40mm pedicle screw
• 03701313000851: Ø5.5 L35mm pedicle screw
• 03701313000844: Ø5.5 L30mm pedicle screw
• 03701313000837: Ø5.5 L25mm pedicle screw
• 03701313000813: Ø4.5 L60mm pedicle screw
• 03701313000806: 24PW45055
• 03701313000790: Ø4.5 L50mm pedicle screw
• 03701313000783: Ø4.5 L45mm pedicle screw
• 03701313000776: Ø4.5 L40mm pedicle screw
• 03701313000769: Ø4.5 L35mm pedicle screw
• 03701313000752: Ø4.5 L30mm pedicle screw
• 03701313000745: Ø4.5 L25mm pedicle screw
• 03701313000257: Ø5.5 L95mm straight Ti rod
• 03701313000240: Ø5.5 L85mm straight Ti rod
• 03701313000233: Ø5.5 L75mm straight Ti rod
• 03701313000226: Ø5.5 L65mm straight Ti rod
• 03701313000219: Ø5.5 L55mm straight Ti rod
• 03701313000202: Ø5.5 L505mm straight Ti rod
• 03701313000196: Ø5.5 L45mm straight Ti rod
• 03701313000189: Ø5.5 L35mm straight Ti rod
• 03701313000172: Ø5.5 L285mm straight Ti rod
• 03701313000165: Ø5.5 L185mm straight Ti rod