SpeedAkin

GUDID 00810111223744

Rapid Compression Implants

Treace Medical Concepts, Inc.

Orthopaedic bone staple, non-adjustable

• Primary Device ID: 00810111223744
• NIH Device Record Key: a5fa5490-5bf4-4bc8-8b45-fdb9352d2448
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpeedAkin
• Version Model Number: SK63
• 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	00810111223744 [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: 2025-02-04
• Device Publish Date: 2025-01-27

Devices Manufactured by Treace Medical Concepts, Inc.

• 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
• 00810111225113 - Blade: 2025-11-21 NanoRasp - ZMS
• 00810111225120 - Blade: 2025-11-21 NanoRasp - SM
• 00810111225137 - Elevator: 2025-10-03 Elevator
• 00810111225106 - Percuplasty Tray: 2025-10-01 Instrument Tray