| 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 | 
| Phone | +97299511511 | 
| info@carbo-fix.com | |
| Phone | +97299511511 | 
| info@carbo-fix.com | |
| Phone | +97299511511 | 
| info@carbo-fix.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 07290109338002 [Primary] | 
| NKB | Thoracolumbosacral Pedicle Screw System | 
| 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
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 4 | 
| Public Version Date | 2018-09-04 | 
| Device Publish Date | 2016-09-18 | 
| 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 | 
| 07290117354834 - CarboClear Posterior Cervical Screw System | 2025-08-25 Screw holder | 
| 07290117353752 - Piccolo Composite Nailing System | 2025-07-15 Wrench for use with the Piccolo Composite Humeral Nailing System | 
| 17290117357658 - CarboClear Modular Hybrid Pedicle Screw System | 2025-05-29 CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw |