WishBone K - Wire System

GUDID B562KWSB0

K-wire sports balls tip proctector, 3 pack

WISHBONE MEDICAL, INC.

Orthopaedic bone wire

• Primary Device ID: B562KWSB0
• NIH Device Record Key: 9dcebccd-d70f-4bbe-adb6-95e8eae0c3e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WishBone K - Wire System
• Version Model Number: KWSB
• Company DUNS: 062355158
• Company Name: WISHBONE MEDICAL, INC.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B562KWSB0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173013

FDA Product Code

• HTY: Pin, Fixation, Smooth
• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-08
• Device Publish Date: 2021-06-30

On-Brand Devices [WishBone K - Wire System]

• B562KWSBUS0: K-wire sports balls tip proctector, 3 pack
• B562KWSB0: K-wire sports balls tip proctector, 3 pack
• B562HDRASS15US0: Hex Driver for K-wire Sports Balls Tip Protectors, 1.5mm
• B562HDRASS150: Hex Driver for K-wire Sports Balls Tip Protectors, 1.5mm