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.

• 00810111222952 - Instrument Tray: 2025-07-24 Instrument Tray
• 00810111223942 - MIS Beveled Screw: 2025-07-24 Beveled Screw
• 00810111223959 - MIS Beveled Screw: 2025-07-24 Beveled Screw
• 00810111223966 - MIS Beveled Screw: 2025-07-24 Beveled Screw
• 00810111223973 - MIS Beveled Screw: 2025-07-24 Beveled Screw
• 00810111223980 - MIS Beveled Screw: 2025-07-24 Beveled Screw
• 00810111224390 - Reamer: 2025-07-24 cone reamer
• 00810111222143 - Drill Guide: 2025-07-09 Drill Guide and Template