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.

• 00810111225489 - Instrument Tray: 2026-03-31 Forefoot Instrument Tray
• 00810111226745 - Instrument Tray: 2026-03-31 VPCS Hindfoot Tray
• 00810111227148 - K-Wire: 2026-03-31 K-Wire
• 00810111225649 - Depth Gage: 2026-03-27 K-Wire Depth Gauge
• 00810111225601 - Reamer: 2026-03-10 Barrel Reamer
• 00810111225618 - Reamer: 2026-03-10 Barrel Reamer
• 00810111225625 - Reamer: 2026-03-10 Barrel Reamer
• 00810111226691 - Positioner / Compressor: 2026-03-02 LIGHTNING BLOCK - PROXIMAL LEFT