Piccolo Composite Plate System DFELN1806

GUDID 07290109335193

A plate inindicated for buttressing multifragmentary distal femur fractures including supra-condylar, intra-articular and extraarticular condylar frac

CARBOFIX ORTHOPEDICS LTD

Orthopaedic fixation plate, non-bioabsorbable, sterile

• Primary Device ID: 07290109335193
• NIH Device Record Key: 7709910f-0454-40a2-9a9e-87fff6d1f3f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Piccolo Composite Plate System
• Version Model Number: Distal Femur Plate
• Catalog Number: DFELN1806
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 171 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109335193 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143496

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-15

On-Brand Devices [Piccolo Composite Plate System]

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