CarboClear Pedicle Screw System PNNS7540

GUDID 07290110204761

Non cannulated pedicle screw (oncology)

CARBOFIX ORTHOPEDICS LTD

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 07290110204761
• NIH Device Record Key: e278fe0c-35bf-44ec-aebe-6fda8a671a4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarboClear Pedicle Screw System
• Version Model Number: Pedicle Screw - Non Cannulated
• Catalog Number: PNNS7540
• 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: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com

Device Dimensions

• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110204761 [Primary]
GS1	17290110204768 [Package]; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173487

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

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: 2018-08-23
• Device Publish Date: 2018-07-23

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