TriLEAP 04.900.251

GUDID 00810112599275

1st MTP Ti Fusion Plate, Extra Small, 6 Hole, 10 Deg, Right

CROSSROADS EXTREMITY SYSTEMS

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00810112599275
• NIH Device Record Key: 700e003c-f8e4-412d-8d57-60776a5c0d6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriLEAP
• Version Model Number: 1st MTP Ti Fusion Plate, Extra Small, 6 Hole, 10 D
• Catalog Number: 04.900.251
• 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	00810112599275 [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

[00810112599275]

Moist Heat or Steam Sterilization

[00810112599275]

Moist Heat or Steam Sterilization

[00810112599275]

Moist Heat or Steam Sterilization

[00810112599275]

Moist Heat or Steam Sterilization

[00810112599275]

Moist Heat or Steam Sterilization

[00810112599275]

Moist Heat or Steam Sterilization

[00810112599275]

Moist Heat or Steam Sterilization

[00810112599275]

Moist Heat or Steam Sterilization

[00810112599275]

Moist Heat or Steam Sterilization

[00810112599275]

Moist Heat or Steam Sterilization

[00810112599275]

Moist Heat or Steam Sterilization

[00810112599275]

Moist Heat or Steam Sterilization

[00810112599275]

Moist Heat or Steam Sterilization

[00810112599275]

Moist Heat or Steam Sterilization

[00810112599275]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-28
• Device Publish Date: 2025-03-20

On-Brand Devices [TriLEAP]

• 00810112599268: 1st MTP Ti Fusion Plate, Extra Small, 6 Hole, 10 Degree, Left
• 00810112599251: 1st MTP Ti Fusion Plate, Extra Small, 6 Hole, 5 Deg, Right
• 00810112599244: 1st MTP Ti Fusion Plate, Extra Small, 6 Hole, 5 Deg, Left
• 00810112599237: 1st MTP Ti Fusion Plate, Extra Small, 6 Hole, 0 Deg, Right
• 00810112599220: 1st MTP Ti Fusion Plate, Extra Small, 6 Hole, 0 Deg, Left
• 00810112599213: 1st MTP Ti Fusion Plate, Extra Small, 5 Hole, 10 Deg, Right
• 00810112599206: 1st MTP Ti Fusion Plate, Extra Small, 5 Hole, 10 Deg, Left
• 00810112599190: 1st MTP Ti Fusion Plate, Extra Small, 5 Hole, 5 Deg, Right
• 00810112599183: 1st MTP Ti Fusion Plate, Extra Small, 5 Hole, 5 Deg, Left
• 00810112599176: 1st MTP Ti Fusion Plate, Extra Small, 5 Hole, 0 Deg, Right
• 00810112599763: Locking Knob For MTP Targeting Guide R/L
• 00810112599169: 1st MTP Ti Fusion Plate, Extra Small, 5 Hole, 0 Deg, Left
• 00810112599275: 1st MTP Ti Fusion Plate, Extra Small, 6 Hole, 10 Deg, Right