TriLeap Lower Extremity Plating System 04.900.057

GUDID 00810112597035

Lateral Ti Talar Neck Plate, Linear

CROSSROADS EXTREMITY SYSTEMS

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00810112597035
• NIH Device Record Key: 56558c83-eb70-4c53-a1a6-56d2a7fb6830
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriLeap Lower Extremity Plating System
• Version Model Number: Lateral Ti Talar Neck Plate, Linear
• Catalog Number: 04.900.057
• 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: true
• 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	00810112597035 [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

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-29
• Device Publish Date: 2024-02-21

Devices Manufactured by CROSSROADS EXTREMITY SYSTEMS

• 00810112599282 - PRO-SPEC: 2025-03-12 EVANS OSTEOTOMY TRIAL 18MMX6MM
• 00810112599299 - PRO-SPEC: 2025-03-12 EVANS OSTEOTOMY TRIAL 18MMX8MM
• 00810112599305 - PRO-SPEC: 2025-03-12 EVANS OSTEOTOMY TRIAL 18MMX10MM
• 00810112599312 - PRO-SPEC: 2025-03-12 EVANS OSTEOTOMY TRIAL 18MMX12MM
• 00810112599329 - PRO-SPEC: 2025-03-12 EVANS OSTEOTOMY TRIAL 20MMX6MM
• 00810112599336 - PRO-SPEC: 2025-03-12 EVANS OSTEOTOMY TRIAL 20MMX8MM
• 00810112592986 - TriLeap Lower Extremity Anatomic Plating System: 2025-02-06 2.0 mm Ti Cortex Screw Length 22 mm, Blue
• 00810112592993 - TriLeap Lower Extremity Anatomic Plating System: 2025-02-06 2.0 mm Ti Cortex Screw Length 24 mm, Blue