Oxford Partial Knee System 32-420384

GUDID 05019279484034

Phase 3 Trial Bearing

Biomet Uk Ltd

Knee tibia prosthesis trial

• Primary Device ID: 05019279484034
• NIH Device Record Key: 33c42319-dcc7-4e44-bc2d-97f4d7acb7c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxford Partial Knee System
• Version Model Number: 32-420384
• Catalog Number: 32-420384
• Company DUNS: 219322575
• Company Name: Biomet Uk Ltd
• 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

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 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	05019279484034 [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: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2014-08-29

On-Brand Devices [Oxford Partial Knee System]

• 05019279999491: 154379
• 05019279999484: 154378
• 05019279999477: 154377
• 05019279999460: 154376
• 05019279999453: 154375
• 05019279999446: 154374
• 05019279999439: 154373
• 05019279999422: 154372
• 05019279999415: 154371
• 05019279786411: Anatomic Meniscal Bearing Right Media
• 05019279786404: Anatomic Meniscal Bearing Right Medial
• 05019279786398: Anatomic Meniscal Bearing Right Medial
• 05019279786381: Anatomic Meniscal Bearing Right Medial
• 05019279786374: Anatomic Meniscal Bearing Right Medial
• 05019279786367: Anatomic Meniscal Bearing Right Medial
• 05019279786350: Anatomic Meniscal Bearing Right Medial
• 05019279786343: Anatomic Meniscal Bearing Right Medial
• 05019279786336: Anatomic Meniscal Bearing Right Medial
• 05019279786329: Anatomic Meniscal Bearing Right Medial
• 05019279786312: Anatomic Meniscal Bearing Right Medial
• 05019279786305: Anatomic Meniscal Bearing Right Medial
• 05019279786299: Anatomic Meniscal Bearing Right Medial
• 05019279786282: Anatomic Meniscal Bearing Right Medial
• 05019279786275: Anatomic Meniscal Bearing Right Medial
• 05019279786268: Anatomic Meniscal Bearing Right Medial
• 05019279786251: Anatomic Meniscal Bearing Right Medial
• 05019279786244: Anatomic Meniscal Bearing Right Medial
• 05019279786237: Anatomic Meniscal Bearing Right Medial
• 05019279786220: Anatomic Meniscal Bearing Right Medial
• 05019279786213: Anatomic Meniscal Bearing Right Medial
• 05019279786206: Anatomic Meniscal Bearing Right Medial
• 05019279786190: Anatomic Meniscal Bearing Right Medial
• 05019279786183: Anatomic Meniscal Bearing Right Medial
• 05019279786176: Anatomic Meniscal Bearing Right Medial
• 05019279786169: Anatomic Meniscal Bearing Right Medial
• 05019279786152: Anatomic Meniscal Bearing Right Medial
• 05019279786145: Anatomic Meniscal Bearing Right Medial
• 05019279786138: Anatomic Meniscal Bearing Left Medial
• 05019279786121: Anatomic Meniscal Bearing Left Medial
• 05019279786114: Anatomic Meniscal Bearing Left Medial
• 05019279786107: Anatomic Meniscal Bearing Left Medial
• 05019279786091: Anatomic Meniscal Bearing Left Medial
• 05019279786084: Anatomic Meniscal Bearing Left Medial
• 05019279786077: Anatomic Meniscal Bearing Left Medial
• 05019279786060: Anatomic Meniscal Bearing Left Medial
• 05019279786053: Anatomic Meniscal Bearing Left Medial
• 05019279786046: Anatomic Meniscal Bearing Left Medial
• 05019279786039: Anatomic Meniscal Bearing Left Medial
• 05019279786022: Anatomic Meniscal Bearing Left Medial
• 05019279786015: Anatomic Meniscal Bearing Left Medial