BioPoly® Radial Head Implant 160-5386

GUDID 00850005618539

BioPoly® Radial Head Implant, 23 x 8(+6)mm

Biopoly, LLC

Elbow radius prosthesis

• Primary Device ID: 00850005618539
• NIH Device Record Key: f5e95e0e-58cf-4002-ba75-05dd59c6176e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioPoly® Radial Head Implant
• Version Model Number: 160-5386
• Catalog Number: 160-5386
• Company DUNS: 023778928
• Company Name: Biopoly, 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: 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

Customer Support Contacts

• Phone: 260-999-6135
• Email: info@biopolyortho.com
• Phone: 260-999-6135
• Email: info@biopolyortho.com
• Phone: 260-999-6135
• Email: info@biopolyortho.com
• Phone: 260-999-6135
• Email: info@biopolyortho.com
• Phone: 260-999-6135
• Email: info@biopolyortho.com
• Phone: 260-999-6135
• Email: info@biopolyortho.com
• Phone: 260-999-6135
• Email: info@biopolyortho.com
• Phone: 260-999-6135
• Email: info@biopolyortho.com
• Phone: 260-999-6135
• Email: info@biopolyortho.com
• Phone: 260-999-6135
• Email: info@biopolyortho.com
• Phone: 260-999-6135
• Email: info@biopolyortho.com
• Phone: 260-999-6135
• Email: info@biopolyortho.com
• Phone: 260-999-6135
• Email: info@biopolyortho.com
• Phone: 260-999-6135
• Email: info@biopolyortho.com
• Phone: 260-999-6135
• Email: info@biopolyortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005618539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233592

FDA Product Code

• KWI: Prosthesis, Elbow, Hemi-, Radial, Polymer

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: 2025-01-10
• Device Publish Date: 2025-01-02

Devices Manufactured by Biopoly, LLC

• 00850005618034 - BioPoly® Radial Head Implant: 2025-01-10 BioPoly® Radial Head Implant, 20 x 6(+0)mm
• 00850005618041 - BioPoly® Radial Head Implant: 2025-01-10 BioPoly® Radial Head Implant, 20 x 6(+3)mm
• 00850005618058 - BioPoly® Radial Head Implant: 2025-01-10 BioPoly® Radial Head Implant, 20 x 6(+6)mm
• 00850005618065 - BioPoly® Radial Head Implant: 2025-01-10 BioPoly® Radial Head Implant, 20 x 7(+0)mm
• 00850005618072 - BioPoly® Radial Head Implant: 2025-01-10 BioPoly® Radial Head Implant, 20 x 7(+3)mm
• 00850005618089 - BioPoly® Radial Head Implant: 2025-01-10 BioPoly® Radial Head Implant, 20 x 7(+6)mm
• 00850005618249 - BioPoly® Radial Head Implant: 2025-01-10 BioPoly® Radial Head Implant, 20 x 8(+0)mm
• 00850005618256 - BioPoly® Radial Head Implant: 2025-01-10 BioPoly® Radial Head Implant, 20 x 8(+3)mm