CarboClear Pedicle Screw System PNNSC7545F

GUDID 17290110204461

Fenestrated pedicle screw (oncology)

CARBOFIX ORTHOPEDICS LTD

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 17290110204461
• NIH Device Record Key: b0f17b6c-b4b9-4117-a8df-bb54c4383dcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarboClear Pedicle Screw System
• Version Model Number: Pedicle Screw - Fenestrated
• Catalog Number: PNNSC7545F
• 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
• 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
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com

Device Dimensions

• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110204464 [Primary]
GS1	17290110204461 [Package]; Contains: 07290110204464; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190526

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: 2019-10-02
• Device Publish Date: 2019-09-24

On-Brand Devices [CarboClear Pedicle Screw System]

• 07290110205041: Gauge for use with the CarboClear Pedicle Screw System trans-connectors.
• 07290110205034: Wrench for use with the CarboClear Pedicle Screw System trans-connectors unlocker.
• 07290110205027: Unlocker for use with the CarboClear Pedicle Screw System trans-connectors.
• 07290110205010: Locking Device for use with the CarboClear Pedicle Screw System trans-connectors.
• 17290110204874: Curved Rod (oncology) of the CarboClear Pedicle Screw System
• 17290110204867: Curved Rod (oncology) of the CarboClear Pedicle Screw System
• 17290110204850: Curved Rod (oncology) of the CarboClear Pedicle Screw System
• 17290110204843: Curved Rod (oncology) of the CarboClear Pedicle Screw System
• 17290110204836: Curved Rod (oncology) of the CarboClear Pedicle Screw System
• 17290110204829: Straight Rod (oncology) of the CarboClear Pedicle Screw System
• 17290110204812: Straight Rod (oncology) of the CarboClear Pedicle Screw System
• 17290110204805: Straight Rod (oncology) of the CarboClear Pedicle Screw System
• 17290110204799: Straight Rod (oncology) of the CarboClear Pedicle Screw System
• 07290110204785: Straight Rod (oncology) of the CarboClear Pedicle Screw System
• 07290110204778: Rod cutting instruments for use with the CarboClear Pedicle Screw System.
• 07290110204761: Non cannulated pedicle screw (oncology)
• 17290110204751: Non cannulated pedicle screw (oncology)
• 07290110204747: Mallet for use with the CarboClear Pedicle Screw System.
• 07290110204730: Distraction device for use with the CarboClear Pedicle Screw System.
• 07290110204723: Rod End Shaper for use with the CarboClear Pedicle Screw System.
• 07290110204716: Saw for use with the CarboClear Pedicle Screw System.
• 07290110204709: Compression device for use with the CarboClear Pedicle Screw System.
• 07290110204693: Pedicle Screw Extractor for use with the CarboClear Pedicle Screw System.
• 07290110204686: Pedicle Screw Extractor for use with the CarboClear Pedicle Screw System.
• 07290110204679: Pedicle Screw Extractor for use with the CarboClear Pedicle Screw System.
• 07290110204662: Unlocker for use with the CarboClear Pedicle Screw System.
• 07290110204655: Locking Element positioning device for use with the CarboClear Pedicle Screw System.
• 07290110204648: Unlocker for use with the CarboClear Pedicle Screw System.
• 07290110204631: Sterilization case for use with the CarboClear Pedicle Screw System.
• 07290110204624: Container for use with the CarboClear Pedicle Screw System.
• 07290110202200: Iliac Crest Rod of the CarboClear Pedicle Screw System
• 07290110202002: Template for use with the CarboClear Pedicle Screw System.
• 07290110201982: Template for use with the CarboClear Pedicle Screw System.
• 07290110201975: Template for use with the CarboClear Pedicle Screw System.
• 07290110201968: Template for use with the CarboClear Pedicle Screw System.
• 17290110201958: Trans-Connector Locking Element (and Ring) for use as part of the CarboClear Pedicle Screw Syste
• 17290110201941: Trans-Connector Rod of the CarboClear Pedicle Screw System
• 17290110201934: Trans-Connector Rod of the CarboClear Pedicle Screw System
• 17290110201927: Trans-Connector Rod of the CarboClear Pedicle Screw System
• 17290110201910: Trans-Connector Rod of the CarboClear Pedicle Screw System
• 17290110201903: Trans-Connector Rod of the CarboClear Pedicle Screw System
• 17290110201897: Trans-Connector Rod of the CarboClear Pedicle Screw System
• 17290110201880: Trans-Connector Rod of the CarboClear Pedicle Screw System
• 17290110201873: Trans-Connector Rod of the CarboClear Pedicle Screw System
• 17290110201866: Trans-Connector Rod of the CarboClear Pedicle Screw System
• 17290110201859: Trans-Connector Rod of the CarboClear Pedicle Screw System
• 17290110201842: Trans-Connector Rod of the CarboClear Pedicle Screw System
• 17290110201835: Trans-Connector Rod of the CarboClear Pedicle Screw System
• 17290110201828: Trans-Connector Rod of the CarboClear Pedicle Screw System
• 17290110201811: Trans-Connector Rod of the CarboClear Pedicle Screw System