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 ID07290109338002
NIH Device Record Key91e90bf1-1a96-4fcd-a4f7-dba8a09e2f4f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePiccolo Composite Nailing System / CarboClear Pedi
Version Model NumberMallet
Catalog NumberQ9105110
Company DUNS649185170
Company NameCARBOFIX ORTHOPEDICS LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97299511511
Emailinfo@carbo-fix.com
Phone+97299511511
Emailinfo@carbo-fix.com
Phone+97299511511
Emailinfo@carbo-fix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109338002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290109338002]

Moist Heat or Steam Sterilization


[07290109338002]

Moist Heat or Steam Sterilization


[07290109338002]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-09-04
Device Publish Date2016-09-18

Devices Manufactured by CARBOFIX ORTHOPEDICS LTD

07290117358450 - Piccolo Composite Nailing System2025-10-03 Nail indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric, high subtr
07290117358467 - Piccolo Composite Nailing System2025-10-03 Nail indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric, high subtr
17290110206601 - CarboClear Pedicle Screw Systems2025-09-04 Straight Rod of the CarboClear Pedicle Screw Systems (MIS)
07290117351062 - CarboClear Posterior Cervical Screw System2025-08-25 Bone Tap for use with the CarboClear Posterior Cervical Screw System
07290117351161 - CarboClear Posterior Cervical Screw System2025-08-25 Drill bit for use with the CarboClear Posterior Cervical Screw System
07290117354834 - CarboClear Posterior Cervical Screw System2025-08-25 Screw holder
07290117353752 - Piccolo Composite Nailing System2025-07-15 Wrench for use with the Piccolo Composite Humeral Nailing System
17290117357658 - CarboClear Modular Hybrid Pedicle Screw System2025-05-29 CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw

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