Oxford Partial Knee System 42-411450

GUDID 00880304510128

Signature Femoral Drill Guide

Biomet Orthopedics, LLC

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00880304510128
• NIH Device Record Key: ed0a422c-70c5-478a-9f77-bd5c9d4e9e44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxford Partial Knee System
• Version Model Number: 42-411450
• Catalog Number: 42-411450
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 1-800-348-9500
• Email: customerservice@biomet.com
• Phone: 1-800-348-9500
• Email: customerservice@biomet.com
• Phone: 1-800-348-9500
• Email: customerservice@biomet.com
• Phone: 1-800-348-9500
• Email: customerservice@biomet.com
• Phone: 1-800-348-9500
• Email: customerservice@biomet.com
• Phone: 1-800-348-9500
• Email: customerservice@biomet.com
• Phone: 1-800-348-9500
• Email: customerservice@biomet.com
• Phone: 1-800-348-9500
• Email: customerservice@biomet.com
• Phone: 1-800-348-9500
• Email: customerservice@biomet.com
• Phone: 1-800-348-9500
• Email: customerservice@biomet.com
• Phone: 1-800-348-9500
• Email: customerservice@biomet.com
• Phone: 1-800-348-9500
• Email: customerservice@biomet.com
• Phone: 1-800-348-9500
• Email: customerservice@biomet.com
• Phone: 1-800-348-9500
• Email: customerservice@biomet.com
• Phone: 1-800-348-9500
• Email: customerservice@biomet.com

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 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	00880304510128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010014

FDA Product Code

• NRA: Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

Sterilization

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

[00880304510128]

Moist Heat or Steam Sterilization

[00880304510128]

Moist Heat or Steam Sterilization

[00880304510128]

Moist Heat or Steam Sterilization

[00880304510128]

Moist Heat or Steam Sterilization

[00880304510128]

Moist Heat or Steam Sterilization

[00880304510128]

Moist Heat or Steam Sterilization

[00880304510128]

Moist Heat or Steam Sterilization

[00880304510128]

Moist Heat or Steam Sterilization

[00880304510128]

Moist Heat or Steam Sterilization

[00880304510128]

Moist Heat or Steam Sterilization

[00880304510128]

Moist Heat or Steam Sterilization

[00880304510128]

Moist Heat or Steam Sterilization

[00880304510128]

Moist Heat or Steam Sterilization

[00880304510128]

Moist Heat or Steam Sterilization

[00880304510128]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-08-29

On-Brand Devices [Oxford Partial Knee System]

• 00880304512047: Right Medial Tibial Alignment
• 00880304511804: Left Medial Tibial Alignment
• 00880304510227: Signature Femoral Drill Guide
• 00880304510210: Signature Femoral Drill Guide
• 00880304510203: Signature Femoral Drill Guide
• 00880304510197: Signature Tibial Drill Guide
• 00880304510180: Signature Femoral Drill Guide
• 00880304510173: Signature Femoral Drill Guide
• 00880304510166: Signature Femoral Drill Guide
• 00880304510159: Signature Femoral Drill Guide
• 00880304510142: Signature Femoral Drill Guide
• 00880304510135: Signature Femoral Drill Guide
• 00880304510128: Signature Femoral Drill Guide
• 00880304510111: Signature Femoral Drill Guide
• 00880304510104: Signature Femoral Drill Guide
• 00880304510098: Signature Femoral Drill Guide