MotoCLIP™ Sizing Templates

GUDID 00815432023226

MotoCLIP™ is a bone staple for use in surgery of the hand and foot bone fragment osteotomy fixation and joint arthrodesis

CROSSROADS EXTREMITY SYSTEMS

Orthopaedic bone staple, non-adjustable

• Primary Device ID: 00815432023226
• NIH Device Record Key: fae3e4de-48c5-48df-8bec-d54d7e77b548
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MotoCLIP™ Sizing Templates
• Version Model Number: 1442-0000
• 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: true
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815432023226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142727

FDA Product Code

• JDR: Staple, 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: 2022-12-08
• Device Publish Date: 2022-11-30

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• 00810112593006 - TriLeap Lower Extremity Anatomic Plating System: 2025-02-06 2.0 mm Ti Cortex Screw Length 26 mm, Blue
• 00810112593013 - TriLeap Lower Extremity Anatomic Plating System: 2025-02-06 2.0 mm Ti Cortex Screw Length 28 mm, Blue
• 00810112593020 - TriLeap Lower Extremity Anatomic Plating System: 2025-02-06 2.0 mm Ti Cortex Screw Length 30 mm, Blue
• 00810112593037 - TriLeap Lower Extremity Anatomic Plating System: 2025-02-06 2.0 mm Ti Variable Angle Screw Length 8 mm, Blue
• 00810112593044 - TriLeap Lower Extremity Anatomic Plating System: 2025-02-06 2.0 mm Ti Variable Angle Screw Length 9 mm, Blue
• 00810112593051 - TriLeap Lower Extremity Anatomic Plating System: 2025-02-06 2.0 mm Ti Variable Angle Screw Length 10 mm, Blue