WishBone Plate & Screw System 51-201-WR0070T-1

GUDID B56251201WR0070T10

7.0 Washer, Ti

WISHBONE MEDICAL, INC.

Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile

• Primary Device ID: B56251201WR0070T10
• NIH Device Record Key: 332cc8f9-4fae-457e-94f5-8c2354acec63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WishBone Plate & Screw System
• Version Model Number: 51-201-WR0070T-1
• Catalog Number: 51-201-WR0070T-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	B56251201WR0070T10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203467

FDA Product Code

• HTN: Washer, Bolt Nut

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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• 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
• B56252201001215G00: 1.25mm x 150mm Smooth Guide Wire
• B56251300SDG000G10: Small Depth Gauge (65mm)
• B56251201WR0070T10: 7.0 Washer, Ti
• B56251201WR0070T00: 7.0 Washer, Ti
• B56251201PWG125G10: Parallel Wire Guide for 1.25mm Wires
• B56251201DMD000G10: 4.0mm Cannulated Screw Direct Measuring Device
• B56251201112715G10: 2.7mm X 150mm Cannulated Drill Bit
• B56251201112715G00: 2.7mm X 150mm Cannulated Drill Bit
• B56251300MDG000G10: Medium Depth Gauge (65mm)