Lapiplasty SpeedPlate

GUDID 00810111222587

Rapid Compression Implants

Treace Medical Concepts, Inc.

Orthopaedic bone staple, non-adjustable

• Primary Device ID: 00810111222587
• NIH Device Record Key: 0d8fdd02-af46-4320-a843-1bff7bfe568c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lapiplasty SpeedPlate
• Version Model Number: SK54
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
GS1	00810111222587 [Primary]

FDA Product Code

• JDR: Staple, 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: 2024-06-11
• Device Publish Date: 2024-06-03

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
• 00810111223607: Micro-Quad™ Inserter Cap 15.5MM