Pediatric Extremity Combo K-Wire System

GUDID B562KITKWIEXMED0

WISHBONE MEDICAL, INC.

Orthopaedic bone wire

• Primary Device ID: B562KITKWIEXMED0
• NIH Device Record Key: bb8d842a-6665-488b-b6d2-4895b170b3ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pediatric Extremity Combo K-Wire System
• Version Model Number: KIT-KWI-EXMED
• 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	B562KITKWIEXMED0 [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: 2019-03-19

On-Brand Devices [Pediatric Extremity Combo K-Wire System]

• B562KITKWIEXMED0: KIT-KWI-EXMED
• B562KITKWIEXLAR0: KIT-KWI-EXLAR