OSS™ Orthopedic Salvage System 151861

GUDID 00887868267154

Biomet Orthopedics, LLC

Femur/tibia shaft prosthesis

• Primary Device ID: 00887868267154
• NIH Device Record Key: 123687f9-997f-4665-8cfd-911c1c48e9c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSS™ Orthopedic Salvage System
• Version Model Number: 151861
• Catalog Number: 151861
• 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: 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@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 Identifiers

Device Issuing Agency	Device ID
GS1	00887868267154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002757

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented
• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-27
• Device Publish Date: 2018-11-13

On-Brand Devices [OSS™ Orthopedic Salvage System]

• 00887868267253: 151871
• 00887868267246: 151870
• 00887868267239: 151869
• 00887868267222: 151868
• 00887868267215: 151867
• 00887868267208: 151866
• 00887868267192: 151865
• 00887868267185: 151864
• 00887868267178: 151863
• 00887868267161: 151862
• 00887868267154: 151861
• 00887868251856: CP102848
• 00887868251849: CP102847
• 00887868251832: CP102846
• 00887868251825: CP102845
• 00887868251818: CP102844
• 00887868251801: CP102843
• 00887868251795: CP102840
• 00887868251788: CP102839
• 00887868251771: CP102838
• 00880304240056: 150489