Cannulated Compression Screw w/ Hexalobular Drive, 3.2mm x 38mm Long

GUDID 00810054092421

Cannulated Compression Screw w/ Hexalobular Drive, 3.2mm x 38mm Long

AVANTI ORTHOPAEDICS LLC

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

• Primary Device ID: 00810054092421
• NIH Device Record Key: 7235c998-5b3a-405f-859d-0e6465bc499c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cannulated Compression Screw w/ Hexalobular Drive, 3.2mm x 38mm Long
• Version Model Number: CH3238
• 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	00810054092421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222967

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00810054092421]

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: 2022-12-09

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