OXFORD® PARTIAL KNEE SYSTEM 42-411402

GUDID 00880304853034

Biomet Orthopedics, LLC

Orthopaedic fixation implant alignment tool

• Primary Device ID: 00880304853034
• NIH Device Record Key: 55cd1022-02ca-4cc2-8419-dbd816a612af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OXFORD® PARTIAL KNEE SYSTEM
• Version Model Number: 42-411402
• Catalog Number: 42-411402
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304853034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110415

FDA Product Code

• OOG: Knee arthroplasty implantation system

Sterilization

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

[00880304853034]

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: 2016-12-05

On-Brand Devices [OXFORD® PARTIAL KNEE SYSTEM]

• 00880304853041: 42-411403
• 00880304853034: 42-411402
• 00880304852228: 42-411450
• 00880304852211: 42-411449
• 00880304852204: 42-411446
• 00880304852198: 42-411445
• 00880304852181: 42-411444
• 00880304852174: 42-411441
• 00880304852167: 42-411440
• 00880304852150: 42-411439
• 00880304852143: 42-411436
• 00880304852136: 42-411435
• 00880304852129: 42-411434
• 00880304852112: 42-411431
• 00880304852105: 42-411430
• 00880304852099: 42-411420