CarboClear Modular Hybrid Pedicle Screw System HMS6535F

GUDID 07290117357644

CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw

CARBOFIX ORTHOPEDICS LTD

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 07290117357644
• NIH Device Record Key: 0097d78e-93bb-47e4-a863-a9964fa614a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarboClear Modular Hybrid Pedicle Screw System
• Version Model Number: Pedicle Screw
• Catalog Number: HMS6535F
• Company DUNS: 649185170
• Company Name: CARBOFIX ORTHOPEDICS LTD
• 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: 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: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com

Device Dimensions

• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290117357644 [Primary]
GS1	17290117357641 [Package]; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240846

FDA Product Code

• PML: Bone Cement, Posterior Screw Augmentation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-27
• Device Publish Date: 2025-05-19

On-Brand Devices [CarboClear Modular Hybrid Pedicle Screw System]

• 07290117357644: CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
• 07290117357637: CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
• 07290117357620: CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
• 07290117357613: CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
• 07290117357606: CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
• 07290117357590: CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
• 17290117357580: CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
• 17290117357733: CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
• 17290117357726: CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
• 17290117357719: CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
• 17290117357702: CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
• 17290117357696: CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
• 17290117357689: CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
• 17290117357672: CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
• 17290117357665: CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
• 17290117357658: CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw