WishBone K-Wire System

GUDID B562PKKWELBUS0

Elbow Fracture Treatment Procedure Kit

WISHBONE MEDICAL, INC.

Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire

• Primary Device ID: B562PKKWELBUS0
• NIH Device Record Key: 5ede55bf-603e-4f65-8a14-32c42fb83c3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WishBone K-Wire System
• Version Model Number: PK-KWELB-US
• 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: true
• 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	B562PKKWELBUS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173013

FDA Product Code

• HTY: Pin, Fixation, Smooth

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: 2020-12-10
• Device Publish Date: 2020-12-02

On-Brand Devices [WishBone K-Wire System]

• B562PKKWEXTUS0: Extremity Fracture Treatment Procedural Kit
• B562PKKWEXT0: Extremity Fracture Treatment Procedural Kit
• B562PKKWELBUS0: Elbow Fracture Treatment Procedure Kit
• B562PKKWELB0: Elbow Fracture Treatment Procedural Kit
• B56251904102025G10: Double K-wire Soft Tissue Protector, 2.00mm/2.50mm
• B56251904101620G10: Double K-wire Soft Tissue Protector, 1.60mm/2.00mm
• B56251904101216G10: Double K-wire Soft Tissue Protector, 1.25mm/1.60mm
• B56251904100912G10: Double K-wire Soft Tissue Protector, 0.90mm/1.25mm
• B56251904100709G10: Double K-wire Soft Tissue Protector, 0.70mm/0.90mm
• B56213904002520S10: 2.50mm x 200mm K-wire
• B56213904002520S00: 2.50mm x 200mm K-wire
• B56213904002020S10: 2.00mm x 200mm K-wire
• B56213904002020S00: 2.00mm x 200mm K-wire
• B56213904001620S10: 1.60mm x 200mm K-wire
• B56213904001620S00: 1.60mm x 200mm K-wire
• B56213904001220S10: 1.25mm x 200mm K-wire
• B56213904001220S00: 1.25mm x 200mm K-wire