SpeedMTP Compression Screws

GUDID 00810111223515

Headless Compression Screws

Treace Medical Concepts, Inc.

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 00810111223515
• NIH Device Record Key: e4876a8d-351f-46fb-904f-2c588a75954a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpeedMTP Compression Screws
• Version Model Number: SK60
• 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: true
• 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	00810111223515 [Primary]

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: 2024-11-14
• Device Publish Date: 2024-11-06

Devices Manufactured by Treace Medical Concepts, Inc.

• 00810111224000 - Olive Wire: 2024-12-25 Threaded Olive Wire
• 00810111223638 - Lapiplasty SpeedPlate - MicroQuad: 2024-12-05 Rapid Compression Implants
• 00810111223645 - Lapiplasty SpeedPlate - MicroQuad: 2024-12-05 Rapid Compression Implants
• 00810111223591 - Drill Guide: 2024-12-03 Drill Guide - 15.5MM
• 00810111223607 - Lapiplasty SpeedPlate: 2024-12-03 Micro-Quad™ Inserter Cap 15.5MM
• 00810111223393 - Drill Guide: 2024-11-27 Drill Guide and Template
• 00810111223409 - Drill Guide: 2024-11-27 Drill Guide and Template
• 00810111223416 - Depth gauge countersink: 2024-11-27 Depth gauge countersink