ORTHOPEDIC SALVAGE SYSTEM 151868

GUDID 00880304688025

Biomet Orthopedics, LLC

Femur/tibia shaft prosthesis

• Primary Device ID: 00880304688025
• NIH Device Record Key: da6fd4ac-6ba6-46b3-9c7e-feaed2b14775
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHOPEDIC SALVAGE SYSTEM
• Version Model Number: 151868
• Catalog Number: 151868
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304688025 [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: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-12-23

On-Brand Devices [ORTHOPEDIC SALVAGE SYSTEM]

• 00880304688056: 151871
• 00880304688049: 151870
• 00880304688032: 151869
• 00880304688025: 151868
• 00880304688018: 151867
• 00880304688001: 151866
• 00880304687998: 151865
• 00880304687981: 151864
• 00880304687974: 151863
• 00880304687967: 151862
• 00880304687950: 151861