TriLeap Lower Etremity Anatomic Plating System 60.900.307

GUDID 00810112592467

Implant Module for Midfoot Fusion Plates

CROSSROADS EXTREMITY SYSTEMS

Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack

• Primary Device ID: 00810112592467
• NIH Device Record Key: b5f9d4e0-785d-4994-8b9c-a47234427b5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriLeap Lower Etremity Anatomic Plating System
• Version Model Number: Implant Module for Midfoot Fusion Plates
• Catalog Number: 60.900.307
• Company DUNS: 058864308
• Company Name: CROSSROADS EXTREMITY SYSTEMS
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00810112592467 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230591

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

[00810112592467]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-04
• Device Publish Date: 2024-02-23

On-Brand Devices [TriLeap Lower Etremity Anatomic Plating System]

• 00810112592566: 2.0 mm Drill Bit for Standard Technique
• 00810112592467: Implant Module for Midfoot Fusion Plates