CrossTIE™ 1443-3301

GUDID 00815432022069

Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.

CROSSROADS EXTREMITY SYSTEMS

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00815432022069
• NIH Device Record Key: 21a2c829-5ddd-401f-a255-15b1b90956fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CrossTIE™
• Version Model Number: 3.0mm 0Deg w/ Universal Inserter
• Catalog Number: 1443-3301
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00815432022069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141857

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-03-09

On-Brand Devices [CrossTIE™ ]

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• 00815432022069: Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the to
• 00815432022052: Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the to
• 00815432022045: Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the to
• 00815432022038: Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the to
• 00850310006557: Intraosseous Fixation Implant to aid in fixation of fractures, fusions, and osteotomies of the t
• 00850310006540: Intraosseous Fixation Implant to aid in fixation of fractures, fusions, and osteotomies of the t
• 00850310006533: The CrossTie™ Intraosseous Fixation System is used to aid in the fixation of fractures, fusion
• 00850310006526: The CrossTie™ Intraosseous Fixation System is used to aid in the fixation of fractures, fusion
• 00850310006519: Intraosseous Fixation Implant to aid in fixation of fractures, fusions, and osteotomies of the t
• 00850310006502: Intraosseous Fixation Implant to aid in fixation of fractures, fusions, and osteotomies of the t
• 00850310006489: Intraosseous Fixation Implant to aid in fixation of fractures, fusions, and osteotomies of the t
• 00850310006487: Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the to
• 00850310006014: Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the to
• 00850310006007: The CrossTie™ Intraosseous Fixation System is used to aid in the fixation of fractures, fusion
• 00850310006496: Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the to