Lapiplasty SpeedPlate

GUDID 00810111222303

Instrument Tray

Treace Medical Concepts, Inc.

Orthopaedic bone staple, non-adjustable

• Primary Device ID: 00810111222303
• NIH Device Record Key: 5ae5d8fb-b2b0-4078-80f4-10d80df3a1ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lapiplasty SpeedPlate
• Version Model Number: NK16
• Company DUNS: 054808082
• Company Name: Treace Medical Concepts, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
GS1	00810111222303 [Primary]

FDA Product Code

• JDR: Staple, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00810111222303]

Moist Heat or Steam Sterilization

[00810111222303]

Moist Heat or Steam Sterilization

[00810111222303]

Moist Heat or Steam Sterilization

[00810111222303]

Moist Heat or Steam Sterilization

[00810111222303]

Moist Heat or Steam Sterilization

[00810111222303]

Moist Heat or Steam Sterilization

[00810111222303]

Moist Heat or Steam Sterilization

[00810111222303]

Moist Heat or Steam Sterilization

[00810111222303]

Moist Heat or Steam Sterilization

[00810111222303]

Moist Heat or Steam Sterilization

[00810111222303]

Moist Heat or Steam Sterilization

[00810111222303]

Moist Heat or Steam Sterilization

[00810111222303]

Moist Heat or Steam Sterilization

[00810111222303]

Moist Heat or Steam Sterilization

[00810111222303]

Moist Heat or Steam Sterilization

[00810111222303]

Moist Heat or Steam Sterilization

[00810111222303]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-22
• Device Publish Date: 2023-11-14

On-Brand Devices [Lapiplasty SpeedPlate]

• 00810111221221: Inserter Cap
• 00810111220798: Rapid Compression Implants
• 00810111221382: Rapid Compression Implants
• 00810111221214: Inserter Cap
• 00810111220637: Inserter Rod
• 00810111220620: Inserter Rod
• 00810111220804: Rapid Compression Implants
• 00810111221672: Rapid Compression Implants
• 00810111222105: Threaded Rods
• 00810111222099: Threaded Rods
• 00810111221788: Rapid Compression Implants
• 00810111221771: Rapid Compression Implants
• 00810111221764: Rapid Compression Implants
• 00810111221757: Inserter Cap
• 00810111221740: Inserter Cap
• 00810111222303: Instrument Tray
• 00810111222396: Rapid Compression Implants
• 00810111222600: Inserter Rod
• 00810111222594: Inserter Cap
• 00810111222587: Rapid Compression Implants
• 00810111220293: Inserter Cap