Pediatric Elbow Combo K-Wire System

GUDID B562KITKWIELBOW0

WISHBONE MEDICAL, INC.

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• Primary Device ID: B562KITKWIELBOW0
• NIH Device Record Key: c18fd435-6e51-47b6-9e2e-32ae82194625
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pediatric Elbow Combo K-Wire System
• Version Model Number: KIT-KWI-ELBOW
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B562KITKWIELBOW0 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-02
• Device Publish Date: 2019-03-18

Devices Manufactured by WISHBONE MEDICAL, INC.

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• B56211705320200S0 - Smart Correction: 2023-07-03 3.0/200/20mm Half Pin, Self-Drilling/Self-Tapping, QC, SS, HA
• B56211705325200S0 - Smart Correction: 2023-07-03 3.0/200/25mm Half Pin, Self-Drilling/Self-Tapping, QC, SS, HA
• B56211705330200S0 - Smart Correction: 2023-07-03 3.0/200/30mm Half Pin, Self-Drilling/Self-Tapping, QC, SS, HA
• B56211705335200S0 - Smart Correction: 2023-07-03 3.0/200/35mm Half Pin, Self-Drilling/Self-Tapping, QC, SS, HA
• B56211705340200S0 - Smart Correction: 2023-07-03 3.0/200/40mm Half Pin, Self-Drilling/Self-Tapping, QC, SS, HA