OSS™ TIBIAL BEARING PROVISIONAL 32-472049

GUDID 00887868458620

Biomet Orthopedics, LLC

Knee tibia prosthesis trial

• Primary Device ID: 00887868458620
• NIH Device Record Key: 9e48af77-d19b-4582-a30d-3ed4a02a9239
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSS™ TIBIAL BEARING PROVISIONAL
• Version Model Number: 32-472049
• Catalog Number: 32-472049
• 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
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.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 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	00887868458620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141331

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

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

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

[00887868458620]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-19
• Device Publish Date: 2020-10-09

On-Brand Devices [OSS™ TIBIAL BEARING PROVISIONAL]

• 00887868458644: 32-472051
• 00887868458637: 32-472050
• 00887868458620: 32-472049
• 00887868458613: 32-472048
• 00887868458606: 32-472047
• 00887868458590: 32-472046