Piccolo Composite Nailing System PCST40450

GUDID 07290109333175

Cortical screw for use with tibia, femur, ankle arthrodesis nails

CARBOFIX ORTHOPEDICS LTD

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID07290109333175
NIH Device Record Key712b0cc9-cda9-4045-b380-df9b17dd4c3f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePiccolo Composite Nailing System
Version Model NumberCortical Screw
Catalog NumberPCST40450
Company DUNS649185170
Company NameCARBOFIX ORTHOPEDICS LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Device Dimensions

Outer Diameter4 Millimeter
Length45 Millimeter
Outer Diameter4 Millimeter
Length45 Millimeter
Outer Diameter4 Millimeter
Length45 Millimeter
Outer Diameter4 Millimeter
Length45 Millimeter
Outer Diameter4 Millimeter
Length45 Millimeter
Outer Diameter4 Millimeter
Length45 Millimeter
Outer Diameter4 Millimeter
Length45 Millimeter
Outer Diameter4 Millimeter
Length45 Millimeter
Outer Diameter4 Millimeter
Length45 Millimeter
Outer Diameter4 Millimeter
Length45 Millimeter
Outer Diameter4 Millimeter
Length45 Millimeter
Outer Diameter4 Millimeter
Length45 Millimeter
Outer Diameter4 Millimeter
Length45 Millimeter
Outer Diameter4 Millimeter
Length45 Millimeter
Outer Diameter4 Millimeter
Length45 Millimeter
Outer Diameter4 Millimeter
Length45 Millimeter
Outer Diameter4 Millimeter
Length45 Millimeter
Outer Diameter4 Millimeter
Length45 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109333175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290109333175]

Moist Heat or Steam Sterilization


[07290109333175]

Moist Heat or Steam Sterilization


[07290109333175]

Moist Heat or Steam Sterilization


[07290109333175]

Moist Heat or Steam Sterilization


[07290109333175]

Moist Heat or Steam Sterilization


[07290109333175]

Moist Heat or Steam Sterilization


[07290109333175]

Moist Heat or Steam Sterilization


[07290109333175]

Moist Heat or Steam Sterilization


[07290109333175]

Moist Heat or Steam Sterilization


[07290109333175]

Moist Heat or Steam Sterilization


[07290109333175]

Moist Heat or Steam Sterilization


[07290109333175]

Moist Heat or Steam Sterilization


[07290109333175]

Moist Heat or Steam Sterilization


[07290109333175]

Moist Heat or Steam Sterilization


[07290109333175]

Moist Heat or Steam Sterilization


[07290109333175]

Moist Heat or Steam Sterilization


[07290109333175]

Moist Heat or Steam Sterilization


[07290109333175]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-15

On-Brand Devices [Piccolo Composite Nailing System]

07290110204389Nail indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteri
07290110202415Cortical screw for use with tibia, femur, ankle arthrodesis nails
07290110202194Sterilization case for use with the Piccolo Composite Humeral Nailing Systems
07290110202187Cortical screw for use with humerus nails
07290110202170Cortical screw for use with humerus nails
07290110202163Cortical screw for use with humerus nails
07290110202156Cortical screw for use with humerus nails
07290110202149Cortical screw for use with humerus nails
07290110202132Cortical screw for use with humerus nails
07290110202118Drill Bit for use with the Piccolo Composite Humeral Nailing System
07290110202101Sleeve for use with the Piccolo Composite Humeral Nailing Systems.
07290110202095Sleeve for use with the Piccolo Composite Humeral Nailing Systems.
07290110202088Proximal humerus nail indicated for simple fractures; severely comminuted, spiral, large oblique
07290110202071Humeral nail indicated for simple fractures; severely comminuted, spiral, large oblique and segm
07290110202064Humeral nail indicated for simple fractures; severely comminuted, spiral, large oblique and segm
07290110202057Humeral nail indicated for simple fractures; severely comminuted, spiral, large oblique and segm
07290110202040Humeral nail indicated for simple fractures; severely comminuted, spiral, large oblique and segm
07290110202033Humeral nail indicated for simple fractures; severely comminuted, spiral, large oblique and segm
07290110202026Humeral nail indicated for simple fractures; severely comminuted, spiral, large oblique and segm
07290110201746Drill Bit for use with the Piccolo Composite Humeral Nailing System
07290110201739Cortical screw for use with humerus nails
07290110201555Lag screw for use with proximal femur nails.
07290110201548Lag screw for use with proximal femur nails.
07290110201531Lag screw for use with proximal femur nails.
07290110201524Lag screw for use with proximal femur nails.
07290110201517Lag screw for use with proximal femur nails.
07290110201500Lag screw for use with proximal femur nails.
07290110201494Lag screw for use with proximal femur nails.
07290110200985An ankle arthrodesis nail indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indica
07290110200978An ankle arthrodesis nail indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indica
07290110200961An ankle arthrodesis nail indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indica
07290110200947Screwdriver for use with the Piccolo Composite Ankle Arthrodesis Nailing System.
07290110200930Wrench for use with the Piccolo Composite Ankle Arthrodesis Nailing System
07290110200923Drill Bit for use with the Piccolo Composite Ankle Arthrodesis Nailing System
07290110200909Depth Gauge for use with the Piccolo Composite Ankle Arthrodesis Nailing System
07290110200893Part of the Piccolo Composite Ankle Arthrodesis Nailing System Handle Assembly.
07290110200886Part of the Piccolo Composite Ankle Arthrodesis Nailing System Handle Assembly.
07290110200879Part of the Piccolo Composite Ankle Arthrodesis Nailing System Handle Assembly.
07290110200862Connects the Piccolo Composite Ankle Arthrodesis Nailing System Handle to the Nail.
07290110200855Part of the Piccolo Composite Ankle Arthrodesis Nailing System Handle Assembly.
07290110200848Part of the Piccolo Composite Ankle Arthrodesis Nailing System Handle Assembly.
07290110200831Part of the Piccolo Composite Ankle Arthrodesis Nailing System Handle Assembly.
07290110200824Handle for use with the Piccolo Composite Ankle Arthrodesis Nailing System
07290110200817Sterilization case for use with the Piccolo Composite Ankle Arthrodesis Nailing System.
07290110200756Unified set screw; part of the Piccolo Composite proximal femur nail.
07290110200633Sterilization case for use with the Piccolo Composite Tibia Nailing System.
07290110200619Awl for use with the Piccolo Composite Tibia Nailing System.
07290110200602Adapter for use with the Piccolo Composite Tibia Nailing System.
07290110200589Instrumentation handle for use with the Piccolo Composite Tibia Nailing System.
07290110200572Trocar for use with the Piccolo Composite Tibia Nailing System.

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