WishBone Plate & Screw System

GUDID B562PKTCX27SMUS0

Procedure Kit- 2.7 mm Cortical Screws (10 mm-16 mm) and Instruments, Ti

WISHBONE MEDICAL, INC.

Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

• Primary Device ID: B562PKTCX27SMUS0
• NIH Device Record Key: 5ee624ee-21ae-47d1-bee4-bba2bda3da2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WishBone Plate & Screw System
• Version Model Number: PK-TCX27SM-US
• 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	B562PKTCX27SMUS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180736

FDA Product Code

• HWC: Screw, Fixation, Bone

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

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• B562PKTCX27SMUS0: Procedure Kit- 2.7 mm Cortical Screws (10 mm-16 mm) and Instruments, Ti
• B562PKTCX27SM0: Procedure Kit- 2.7 mm Cortical Screws (10 mm-16 mm) and Instruments, Ti
• B562PKTCX27LGUS0: Procedure Kit- 2.7 mm Cortical Screws (18mm-24mm) and Instruments, Ti
• B562PKTCX27LG0: Procedure Kit- 2.7 mm Cortical Screws (18mm-24mm) and Instruments, Ti
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• B56252201021215G10: 1.25mm x 150mm Threaded Guide Wire
• B56252201021215G00: 1.25mm x 150mm Threaded Guide Wire
• B56252201001215G10: 1.25mm x 150mm Smooth Guide Wire
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• B56251300SDG000G10: Small Depth Gauge (65mm)
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• B56251201WR0070T00: 7.0 Washer, Ti
• B56251201PWG125G10: Parallel Wire Guide for 1.25mm Wires
• B56251201DMD000G10: 4.0mm Cannulated Screw Direct Measuring Device
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• B56251300MDG000G10: Medium Depth Gauge (65mm)