Piccolo Composite Nailing System / CarboClear Pedi Q9105110

GUDID 07290109338002

Mallet for use with the Piccolo Composite Humeral, Tibial, Femoral,Proximal Femur and Ankle Arthrodesis Nailing Systems, and with the CarboClear Pedic

CARBOFIX ORTHOPEDICS LTD

Surgical mallet

• Primary Device ID: 07290109338002
• NIH Device Record Key: 91e90bf1-1a96-4fcd-a4f7-dba8a09e2f4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Piccolo Composite Nailing System / CarboClear Pedi
• Version Model Number: Mallet
• Catalog Number: Q9105110
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109338002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091425

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[07290109338002]

Moist Heat or Steam Sterilization

[07290109338002]

Moist Heat or Steam Sterilization

[07290109338002]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-04
• Device Publish Date: 2016-09-18

Devices Manufactured by CARBOFIX ORTHOPEDICS LTD

• 17290109335855 - CarboClear Pedicle Screw Systems: 2025-12-03 Straight Rod of the CarboClear Pedicle Screw Systems
• 27290109335968 - CarboClear Pedicle Screw Systems: 2025-12-03 Curved Rod of the CarboClear Pedicle Screw Systems
• 07290117358429 - CarboClear Hybrid Pedicle Screw System: 2025-11-25 Distractor-Compressor MIS Arm
• 07290117358450 - Piccolo Composite Nailing System: 2025-10-03 Nail indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric, high subtr
• 07290117358467 - Piccolo Composite Nailing System: 2025-10-03 Nail indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric, high subtr
• 17290110206601 - CarboClear Pedicle Screw Systems: 2025-09-04 Straight Rod of the CarboClear Pedicle Screw Systems (MIS)
• 07290117351062 - CarboClear Posterior Cervical Screw System: 2025-08-25 Bone Tap for use with the CarboClear Posterior Cervical Screw System
• 07290117351161 - CarboClear Posterior Cervical Screw System: 2025-08-25 Drill bit for use with the CarboClear Posterior Cervical Screw System