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

Devices Manufactured by CROSSROADS EXTREMITY SYSTEMS

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• 00850310006373 - CrossTIE™ Head Drill 5.0mm Cannulated: 2024-09-11 Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe,
• 00850310006380 - CrossTIE™ H10 Driver Cannulated: 2024-09-11 Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe,
• 00850310006397 - CrossTIE™ 2.0mm Hex Driver Cannulated: 2024-09-11 Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe,
• 00850310006403 - CrossTIE™ Head Drill 3.0mm Cannulated: 2024-09-11 Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe,
• 00850310006434 - CrossTIE™ Reamer 2.2mm: 2024-09-11 Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe,
• 00850310006441 - CrossTIE™ Reamer 2.5mm: 2024-09-11 Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe,
• 00850310006458 - CrossTIE™ Reamer 2.7mm: 2024-09-11 Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe,