Lapiplasty Mini Incision System

GUDID 00853114006211

Anatomic Biplanar Implants

TREACE MEDICAL CONCEPTS, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00853114006211
• NIH Device Record Key: 91b985d7-2e6c-4f16-9de1-0e7ffd407f52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lapiplasty Mini Incision System
• Version Model Number: SK30
• 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	00853114006211 [Primary]

FDA Product Code

• HRS: Plate, 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: 2021-01-25
• Device Publish Date: 2021-01-15

Devices Manufactured by TREACE MEDICAL CONCEPTS, INC.

• 00810111222792 - Cut Guide: 2024-04-19 STEPPED INLINE CUT GUIDE, SMALL
• 00810111222808 - Cut Guide: 2024-04-19 STEPPED INLINE CUT GUIDE, MEDIUM
• 00810111222815 - Cut Guide: 2024-04-19 STEPPED INLINE CUT GUIDE, LARGE
• 00810111222723 - TMC PSI Cut Guide System: 2024-03-19 Cut Guide
• 00810111222730 - TMC PSI Cut Guide System: 2024-03-19 Cut Guide
• 00810111222396 - Lapiplasty SpeedPlate: 2024-02-22 Rapid Compression Implants
• 00810111221849 - Derotation Pin Guide: 2024-02-13 Derotation Pin Guide
• 00810111222013 - Instrument Tray: 2024-01-30 Instrument Tray