Lapiplasty

GUDID 00853114006198

4.0 Headless

TREACE MEDICAL CONCEPTS, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00853114006198
• NIH Device Record Key: 91569103-336a-4551-a98e-ffe04abccf04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lapiplasty
• Version Model Number: SK26
• 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	00853114006198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172617

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: 2020-04-07
• Device Publish Date: 2020-03-30

On-Brand Devices [Lapiplasty]

• 00853114006112: 2.5mm Headless Screw
• 00853114006075: 3.5mm Transverse Screw
• 00853114006068: 3.0mm Interfrag Screw
• 00853114006198: 4.0 Headless
• 00853114006174: 4.0 Interfrag