WishBone K-Wire System

GUDID B562PKKWELB0

Elbow Fracture Treatment Procedural Kit

WISHBONE MEDICAL, INC.

Orthopaedic bone wire

• Primary Device ID: B562PKKWELB0
• NIH Device Record Key: 5a159fd9-981f-4057-bc6f-ff57318fce59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WishBone K-Wire System
• Version Model Number: PK-KWELB
• 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	B562PKKWELB0 [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