K-Wire

Basic Information

• Brand Name: K-Wire
• Primary DI: B562PK301ELB2000
• Version / Model: PK-301-ELB200
• Company Name: Wishbone Medical, Inc.
• Labeler DUNS: 062355158
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-16
• Public Version: 4
• Public Version Date: 2024-01-03
• Public Version Status: Update
• Public Device Record Key: 669a78c3-147d-44e8-b65a-d1ff9204837d

Device Description

Elbow Fracture Kit - 2.00mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTY	Pin, Fixation, Smooth	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46651	Spinal bone screw, non-bioabsorbable	A small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B562PK301ELB2000	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173013	000