CarboClear Pedicle Screw Systems PPLSR6080

GUDID 17290109335947

Straight Rod of the CarboClear X Pedicle Screw System (MIS)

CARBOFIX ORTHOPEDICS LTD

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 17290109335947
• NIH Device Record Key: 7024be2f-447d-4b13-aeea-2ef72617e64d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarboClear Pedicle Screw Systems
• Version Model Number: Straight Rod
• Catalog Number: PPLSR6080
• Company DUNS: 649185170
• Company Name: CARBOFIX ORTHOPEDICS LTD
• Device Count: 2
• 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
• 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 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 80 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109335940 [Primary]
GS1	17290109335947 [Package]; Contains: 07290109335940; Package: [2 Units]; In Commercial Distribution
GS1	27290109335944 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231280

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

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: 2023-09-27
• Device Publish Date: 2023-09-19

On-Brand Devices [CarboClear Pedicle Screw Systems]

• 17290117351243: Curved Rod of the CarboClear Pedicle Screw Systems (MIS)
• 17290109336050: Straight Rod of the CarboClear X Pedicle Screw System (MIS)
• 17290109336043: Straight Rod of the CarboClear X Pedicle Screw System (MIS)
• 17290109336036: Straight Rod of the CarboClear X Pedicle Screw System (MIS)
• 17290109336029: Straight Rod of the CarboClear X Pedicle Screw System (MIS)
• 17290109336012: Straight Rod of the CarboClear X Pedicle Screw System (MIS)
• 17290109336005: Straight Rod of the CarboClear X Pedicle Screw System (MIS)
• 17290109335992: Straight Rod of the CarboClear X Pedicle Screw System (MIS)
• 17290109335985: Straight Rod of the CarboClear X Pedicle Screw System (MIS)
• 17290109335978: Straight Rod of the CarboClear X Pedicle Screw System (MIS)
• 17290109335947: Straight Rod of the CarboClear X Pedicle Screw System (MIS)
• 17290109335930: Straight Rod of the CarboClear X Pedicle Screw System (MIS)
• 17290109335923: Straight Rod of the CarboClear X Pedicle Screw System (MIS)
• 17290109335916: Straight Rod of the CarboClear X Pedicle Screw System (MIS)
• 17290109335909: Straight Rod of the CarboClear X Pedicle Screw System (MIS)
• 27290109335890: Straight Rod of the CarboClear X Pedicle Screw System (MIS)
• 17290109335886: Straight Rod of the CarboClear X Pedicle Screw System (MIS)
• 17290109335879: Straight Rod of the CarboClear X Pedicle Screw System (MIS)
• 17290109335862: Straight Rod of the CarboClear X Pedicle Screw System (MIS)