OSS SPLINED STEM TRIAL 110018742

GUDID 00880304679276

Biomet Orthopedics, LLC

Knee femur prosthesis trial

• Primary Device ID: 00880304679276
• NIH Device Record Key: f06e132e-eec3-4b3c-a858-612553a993ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSS SPLINED STEM TRIAL
• Version Model Number: 110018742
• Catalog Number: 110018742
• 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: true
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304679276 [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

[00880304679276]

Moist Heat or Steam Sterilization

[00880304679276]

Moist Heat or Steam Sterilization

[00880304679276]

Moist Heat or Steam Sterilization

[00880304679276]

Moist Heat or Steam Sterilization

[00880304679276]

Moist Heat or Steam Sterilization

[00880304679276]

Moist Heat or Steam Sterilization

[00880304679276]

Moist Heat or Steam Sterilization

[00880304679276]

Moist Heat or Steam Sterilization

[00880304679276]

Moist Heat or Steam Sterilization

[00880304679276]

Moist Heat or Steam Sterilization

[00880304679276]

Moist Heat or Steam Sterilization

[00880304679276]

Moist Heat or Steam Sterilization

[00880304679276]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-10-27

On-Brand Devices [OSS SPLINED STEM TRIAL]

• 00880304679276: 110018742
• 00880304679269: 110018741
• 00880304679252: 110018740
• 00880304679245: 110018739
• 00880304679238: 110018738
• 00880304679221: 110018737