Pediatric Nailing Platform | Tibia

Basic Information

• Brand Name: Pediatric Nailing Platform | Tibia
• Primary DI: 00840194429085
• Version / Model: 01-1510-0041
• Catalog Number: 01-1510-0041
• Company Name: ORTHOPEDIATRICS CORP.
• Labeler DUNS: 796416191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-11
• Public Version: 1
• Public Version Date: 2023-10-19
• Public Version Status: New
• Public Device Record Key: 9fcab564-dc1e-4703-85c6-2f03efc81e61

Device Description

3.2mm x 330mm K-Wire, Threaded, 316L

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: Yes
• 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
KIJ	Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66934	Orthopaedic intraoperative positioning pin, reusable	A nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840194429085	GS1