Orthopedic Salvage System (OSS™) / Arcos® 110024556

GUDID 00887868347696

Biomet Orthopedics, LLC

Femoral stem prosthesis trial

• Primary Device ID: 00887868347696
• NIH Device Record Key: 3edca997-517f-4fb9-b320-c49ab1fee0ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthopedic Salvage System (OSS™) / Arcos®
• Version Model Number: 110024556
• Catalog Number: 110024556
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868347696 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152621

FDA Product Code

• KRO: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[00887868347696]

Moist Heat or Steam Sterilization

[00887868347696]

Moist Heat or Steam Sterilization

[00887868347696]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-18
• Device Publish Date: 2020-05-08

On-Brand Devices [Orthopedic Salvage System (OSS™) / Arcos®]

• 00880304683068: 110024552
• 00887868347795: 110028036
• 00887868347788: 110027910
• 00887868347771: 110024564
• 00887868347764: 110024563
• 00887868347757: 110024562
• 00887868347740: 110024561
• 00887868347733: 110024560
• 00887868347726: 110024559
• 00887868347719: 110024558
• 00887868347702: 110024557
• 00887868347696: 110024556
• 00887868347689: 110024555
• 00887868347672: 110024554