WishBone K-Wire System 13-904-001220S-1

GUDID B56213904001220S10

1.25mm x 200mm K-wire

WISHBONE MEDICAL, INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: B56213904001220S10
• NIH Device Record Key: 5b5c15c5-2bfe-4d22-974d-b4f9046ec292
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WishBone K-Wire System
• Version Model Number: 13-904-001220S-1
• Catalog Number: 13-904-001220S-1
• 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: false
• 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	B56213904001220S10 [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: 2022-07-26
• Device Publish Date: 2022-07-18

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• B56213904002020S10: 2.00mm x 200mm K-wire
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• B56213904001220S10: 1.25mm x 200mm K-wire
• B56213904001220S00: 1.25mm x 200mm K-wire