Pediatric Extremity Combo K-Wire System-SMALL

GUDID B562KITKWIEXSML0

WISHBONE MEDICAL, INC.

Orthopaedic bone wire

• Primary Device ID: B562KITKWIEXSML0
• NIH Device Record Key: f4b9eec9-3019-48a1-8632-20db088297b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pediatric Extremity Combo K-Wire System-SMALL
• Version Model Number: KIT-KWI-EXSML
• 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	B562KITKWIEXSML0 [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: 2019-03-28

Devices Manufactured by WISHBONE MEDICAL, INC.

• B562PKGS000100 - Micro Surgery Kit: 2025-01-07 Surgical convenience kit provided sterile.
• B562PKGS000200 - Minor Surgery Kit: 2025-01-07
• B56251300MDG000G10 - WishBone Plate & Screw System: 2024-01-09 Medium Depth Gauge (65mm)
• B56211705310200S0 - Smart Correction: 2023-07-03 3.0/200/10mm Half Pin, Self-Drilling/Self-Tapping, QC, SS, HA
• B56211705315200S0 - Smart Correction: 2023-07-03 3.0/200/15mm Half Pin, Self-Drilling/Self-Tapping, QC, SS, HA
• 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