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.

• 00810111224208 - Saw Blade: 2025-04-03 Akin Saw Blade - SM
• 00810111224468 - Corner Chisel: 2025-04-02 Corner Chisel
• 00810111224529 - Saw Blade: 2025-04-02 FeatherRasp - S
• 00810111224536 - Saw Blade: 2025-04-02 FeatherRasp - L
• 00810111224543 - Scalpel: 2025-04-02 GREATRELEASE™
• 00810111224178 - Allograft Tamp: 2025-04-01 TMC Allograft Tamp
• 00810111224079 - Lapidus Trial: 2025-03-27 TMC Lapidus Trial, 5mm
• 00810111224086 - Lapidus Trial: 2025-03-27 TMC Lapidus Trial, 9mm