Piccolo Composite Plate System

Basic Information

• Brand Name: Piccolo Composite Plate System
• Primary DI: 07290110200916
• Version / Model: Torque Limiter
• Catalog Number: PL920080
• Company Name: CARBOFIX ORTHOPEDICS LTD
• Labeler DUNS: 649185170
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-27
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 0ecb25a2-78e5-4d51-8755-9fba0d5bc91d

Device Description

Torque Limiter for use with the Piccolo Composite Distal Radius Plate System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	888.3030	2
HRS	Plate, Fixation, Bone	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47858	Surgical instrument torque limiter	A small device designed to attach to a surgical power tool (e.g., the proximal end of a surgical drill handpiece) or a manual surgical instrument (e.g., a screwdriver) to define the torque effect of that tool allowing the surgeon to apply the correct torque, e.g., when tightening an orthopaedic fixation screw during a surgical intervention. It is typically made of high-grade stainless steel or synthetic materials and includes a built-in clutch mechanism. It is available in various shapes, sizes and torque ranges. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290110200916	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K102597	000
K160002	000