TriLeap Lower Extremity Anatomic Plating System 04.910.052

GUDID 00810112595024

3.5 mm Ti Variable Angle Screw Length 52 mm, Dark Purple

CROSSROADS EXTREMITY SYSTEMS

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 00810112595024
• NIH Device Record Key: 4f862984-df37-423f-b7e3-fffa45f170b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriLeap Lower Extremity Anatomic Plating System
• Version Model Number: 3.5 mm Ti Variable Angle Screw Length 52 mm, Dark
• Catalog Number: 04.910.052
• 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	00810112595024 [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

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

[00810112595024]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-03-04
• Device Publish Date: 2024-02-23

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

• 00810112593563: 2.5 mm Ti Variable Angle Screw Length 32 mm, Magenta
• 00810112593570: 2.5 mm Ti Variable Angle Screw Length 34 mm, Magenta
• 00810112595765: 1st MTP Ti Fusion Revision Plate, Medium, 5 Deg, Right
• 00810112592481: Bending Pin for 3.0/3.5/4.0 Plates
• 00810112595871: 1st & 2nd Ti Lisfranc Joint Fusion Plate, Medium, Left
• 00810112595864: 1st & 2nd Ti Lisfranc Joint Fusion Plate, Small, Right
• 00810112595857: 1st & 2nd Ti Lisfranc Joint Fusion Plate, Small, Left
• 00810112595840: Lapidus Ti Plate, Medial, Long
• 00810112595833: Lapidus Ti Plate, Medial, Short
• 00810112595826: Lapidus Ti Plate 4 mm Step, Right
• 00810112595819: Lapidus Ti Plate 4 mm Step, Left
• 00810112595802: Lapidus Ti Plate 2 mm Step, Right
• 00810112595796: Lapidus Ti Plate 2 mm Step, Left
• 00810112595789: Lapidus Ti Plate 0 mm Step, Right
• 00810112595772: Lapidus Ti Plate 0 mm Step, Left
• 00810112595758: 1st MTP Ti Fusion Revision Plate, Medium, 5 Deg, Left
• 00810112595741: 1st MTP Ti Fusion Revision Plate, Medium, 0 Deg, Right
• 00810112595734: 1st MTP Ti Fusion Revision Plate, Medium, 0 Deg, Left
• 00810112595727: 1st MTP Ti Fusion Revision Plate, Small, 5 Deg, Right
• 00810112595710: 1st MTP Ti Fusion Revision Plate, Small, 5 Deg, Left
• 00810112595703: 1st MTP Ti Fusion Revision Plate, Small, 0 Deg, Right
• 00810112595697: 1st MTP Ti Fusion Revision Plate, Small, 0 Deg, Left
• 00810112595680: 1st MTP Ti Fusion Plate, Medium, 5 Deg, Right
• 00810112595673: 1st MTP Ti Fusion Plate, Medium, 5 Deg, Left
• 00810112595666: 1st MTP Ti Fusion Plate, Medium, 10 Deg, Right
• 00810112595659: 1st MTP Ti Fusion Plate, Medium, 10 Deg, Left
• 00810112595642: 1st MTP Ti Fusion Plate, Medium, 0 Deg, Right
• 00810112595635: 1st MTP Ti Fusion Plate, Medium, 0 Deg, Left
• 00810112595628: 1st MTP Ti Fusion Plate, Small, 5 Deg, Right
• 00810112595611: 1st MTP Ti Fusion Plate, Small, 5 Deg, Left
• 00810112595604: 1st MTP Ti Fusion Plate, Small, 10 Deg, Right
• 00810112595598: 1st MTP Ti Fusion Plate, Small, 10 Deg, Left
• 00810112595581: 1st MTP Ti Fusion Plate, Small, 0 Deg, Right
• 00810112595574: 1st MTP Ti Fusion Plate, Small, 0 Deg, Left
• 00810112597172: 2.0 Y-Shape Ti Fracture Plate, 6 Hole
• 00810112597165: 2.0 Y-Shape Ti Fracture Plate, 5 Hole
• 00810112597158: 2.0 Y-Shape Ti Fracture Plate, 4 Hole
• 00810112597141: 2.0 Y-Shape Ti Fracture Plate, 3 Hole
• 00810112597134: 2.0 T-Shape Ti Fracture Plate, 6 Hole
• 00810112597127: 2.0 T-Shape Ti Fracture Plate, 5 Hole
• 00810112597110: 2.0 T-Shape Ti Fracture Plate, 4 Hole
• 00810112597103: 2.0 T-Shape Ti Fracture Plate, 3 Hole
• 00810112597097: 2.0 Straight Ti Fracture Plate, 8 Hole
• 00810112597080: 2.0 Straight Ti Fracture Plate, 7 Hole
• 00810112597073: 2.0 Straight Ti Fracture Plate, 6 Hole
• 00810112597066: 2.0 Straight Ti Fracture Plate, 5 Hole
• 00810112597059: 2.0 Straight Ti Fracture Plate, 4 Hole
• 00810112597042: 2.0 Straight Ti Fracture Plate, 3 Hole
• 00810112596120: Cuboid H Ti Plate, Right
• 00810112596113: Cuboid H Ti Plate, Left