TMC FastPitch Screws

GUDID 00810111224918

Locking Screws

Treace Medical Concepts, Inc.

Orthopaedic bone staple, non-adjustable

• Primary Device ID: 00810111224918
• NIH Device Record Key: 205879b5-1494-413d-96e4-2ab719a7fdcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TMC FastPitch Screws
• Version Model Number: SD31
• 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	00810111224918 [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: 2025-12-22
• Device Publish Date: 2025-12-12

Devices Manufactured by Treace Medical Concepts, Inc.

• 00810111224918 - TMC FastPitch Screws: 2025-12-22Locking Screws
• 00810111224918 - TMC FastPitch Screws: 2025-12-22 Locking Screws
• 00810111225175 - TMC SpeedTMT: 2025-12-22 Inserter Cap
• 00810111225199 - TMC SpeedTMT: 2025-12-22 Rapid Compression Implants
• 00810111225373 - TMC SpeedTMT: 2025-12-22 Inserter Rod
• 00810111225151 - Drill Guide: 2025-12-04 Drill Guide and Template
• 00810111225311 - K-Wire: 2025-11-28 Percuplasty 1.6 x 152mm K-Wire
• 00810111225328 - K-Wire: 2025-11-28 Percuplasty 1.4 x 152mm K-wire
• 00810111224857 - TMC SpeedMTP: 2025-11-24 Rapid Compression Implants