Compression K-Wire, 1.6mm x 120mm Long

GUDID 00810054090922

Compression K-Wire, 1.6mm x 120mm Long

AVANTI ORTHOPAEDICS LLC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00810054090922
• NIH Device Record Key: 86045f30-75c4-4a9c-9cdb-c876f218bb7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compression K-Wire, 1.6mm x 120mm Long
• Version Model Number: CK1600
• Company DUNS: 043505370
• Company Name: AVANTI ORTHOPAEDICS LLC
• 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: true
• 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

Customer Support Contacts

• Phone: 610 316 7345
• Email: info@avantiortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810054090922 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191118

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00810054090922]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-02-19
• Device Publish Date: 2020-06-18

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