Piccolo Composite Plate System PTLCST35750

GUDID 07290110208073

Locking screw for use with proximal tibia plate

CARBOFIX ORTHOPEDICS LTD

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID07290110208073
NIH Device Record Keya621ac49-d276-4d79-b3fa-69a79309a3ce
Commercial Distribution StatusIn Commercial Distribution
Brand NamePiccolo Composite Plate System
Version Model NumberLocking Screw, Ø3.5mm x 75mm
Catalog NumberPTLCST35750
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 Diameter3.5 Millimeter
Length75 Millimeter
Outer Diameter3.5 Millimeter
Length75 Millimeter
Outer Diameter3.5 Millimeter
Length75 Millimeter
Outer Diameter3.5 Millimeter
Length75 Millimeter
Outer Diameter3.5 Millimeter
Length75 Millimeter
Outer Diameter3.5 Millimeter
Length75 Millimeter
Outer Diameter3.5 Millimeter
Length75 Millimeter
Outer Diameter3.5 Millimeter
Length75 Millimeter
Outer Diameter3.5 Millimeter
Length75 Millimeter
Outer Diameter3.5 Millimeter
Length75 Millimeter
Outer Diameter3.5 Millimeter
Length75 Millimeter
Outer Diameter3.5 Millimeter
Length75 Millimeter
Outer Diameter3.5 Millimeter
Length75 Millimeter
Outer Diameter3.5 Millimeter
Length75 Millimeter
Outer Diameter3.5 Millimeter
Length75 Millimeter
Outer Diameter3.5 Millimeter
Length75 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107290110208073 [Primary]
GS107290110208073 [Primary]
GS107290110208073 [Primary]
GS107290110208073 [Primary]
GS107290110208073 [Primary]
GS107290110208073 [Primary]
GS107290110208073 [Primary]
GS107290110208073 [Primary]
GS107290110208073 [Primary]
GS107290110208073 [Primary]
GS107290110208073 [Primary]
GS107290110208073 [Primary]
GS107290110208073 [Primary]
GS107290110208073 [Primary]
GS107290110208073 [Primary]
GS107290110208073 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290110208073]

Moist Heat or Steam Sterilization


[07290110208073]

Moist Heat or Steam Sterilization


[07290110208073]

Moist Heat or Steam Sterilization


[07290110208073]

Moist Heat or Steam Sterilization


[07290110208073]

Moist Heat or Steam Sterilization


[07290110208073]

Moist Heat or Steam Sterilization


[07290110208073]

Moist Heat or Steam Sterilization


[07290110208073]

Moist Heat or Steam Sterilization


[07290110208073]

Moist Heat or Steam Sterilization


[07290110208073]

Moist Heat or Steam Sterilization


[07290110208073]

Moist Heat or Steam Sterilization


[07290110208073]

Moist Heat or Steam Sterilization


[07290110208073]

Moist Heat or Steam Sterilization


[07290110208073]

Moist Heat or Steam Sterilization


[07290110208073]

Moist Heat or Steam Sterilization


[07290110208073]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-23
Device Publish Date2021-02-15

On-Brand Devices [Piccolo Composite Plate System]

07290110205119Template for use with the Piccolo Composite Lapidus Plate System
07290110205102Template for use with the Piccolo Composite Lapidus Plate System
07290110205096Template for use with the Piccolo Composite Lapidus Plate System
07290110205072A plate indicated for fusion and arthrodesis of the 1st tarsometatarsal joint (Lapidus Fusions)
07290110205065A plate indicated for fusion and arthrodesis of the 1st tarsometatarsal joint (Lapidus Fusions)
07290110205058A plate indicated for fusion and arthrodesis of the 1st tarsometatarsal joint (Lapidus Fusions)
07290110204372Template for use with the Piccolo Composite Broad Diaphyseal Plate System
07290110202262Sterilization case for use with the Piccolo Composite MTP Plate System.
07290110201708A plate indicated for treatment of deformations, fractures, nonunions and replantations of the 1
07290110201692A plate indicated for treatment of deformations, fractures, nonunions and replantations of the 1
07290110201630A plate indicated for treatment of deformations, fractures, nonunions and replantations of the 1
07290110201623A plate indicated for treatment of deformations, fractures, nonunions and replantations of the 1
07290110201487Holding device for use with the Piccolo Composite MTP Plate System
07290110201470Sleeve for use with the Piccolo Composite Foot and Ankle Plate Systems
07290110201463Non-locking screw for use with distal fibula, MTP and Lapidus plates
07290110201456Non-locking screw for use with distal fibula, MTP and Lapidus plates
07290110201449Locking screw for use with distal fibula, MTP and Lapidus plates
07290110201432Locking screw for use with distal fibula, MTP and Lapidus plates
07290110201425A plate indicated for treatment of deformations, fractures, nonunions and replantations of the 1
07290110201418Targeting Guide for use with the Piccolo Composite Proximal Humerus Plate System
07290110201296Cannulated screw for use with the foot and ankle plates (MTP, Lapidus)
07290110201289Cannulated screw for use with the foot and ankle plates (MTP, Lapidus)
07290110201272Cannulated screw for use with the foot and ankle plates (MTP, Lapidus)
07290110201265Cannulated screw for use with the foot and ankle plates (MTP, Lapidus)
07290110201258Cannulated screw for use with the foot and ankle plates (MTP, Lapidus)
07290110201241Cannulated screw for use with the foot and ankle plates (MTP, Lapidus)
07290110201234Cannulated screw for use with the foot and ankle plates (MTP, Lapidus)
07290110201227Cannulated screw for use with the foot and ankle plates (MTP, Lapidus)
07290110201210Cannulated screw for use with the foot and ankle plates (MTP, Lapidus)
07290110201203Cannulated screw for use with the foot and ankle plates (MTP, Lapidus)
07290110201074Depth Gauge for use with the Piccolo Composite MTP Plate System.
07290110201067Template for use with the Piccolo Composite MTP Plate System
07290110201050Template for use with the Piccolo Composite MTP Plate System
07290110201043Drill Bit for use with the Piccolo Composite MTP Plate System
07290110201036Screwdriver for use with the Piccolo Composite MTP Plate System.
07290110201029K-Wire for use with the Piccolo Composite MTP Plate System
07290110201012K-Wire for use with the Piccolo Composite MTP Plate System
07290110201005K-Wire for use with the Piccolo Composite MTP Plate System
07290110200992A plate indicated for treatment of deformations, fractures, nonunions and replantations of the 1
07290110200916Torque Limiter for use with the Piccolo Composite Distal Radius Plate System
07290110200749Periosteal Elevator for use with the Piccolo Composite Distal Radius Plate Systems
07290110200732Retractor for use with the Piccolo Composite Distal Radius Plate Systems
07290110200541Sterilization case for use with the Piccolo Composite Distal Radius Plate Systems
07290110200510Retractor for use with the Piccolo Composite Distal Radius Plate Systems
07290110200503Sleeve for use with the Piccolo Composite Distal Radius Plate Systems
07290110200480Sterilization case for use with the Piccolo Composite Foot and Ankle Plate Systems
07290109339931Template for use with the Piccolo Composite Distal Radius Plate System
07290109339924Template for use with the Piccolo Composite Distal Radius Plate System
07290109339917Template for use with the Piccolo Composite Distal Radius Plate System
07290109339900Template for use with the Piccolo Composite Distal Radius Plate System

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