RX90 REVISION HIP SYSTEM 129114

GUDID 00880304008397

Biomet Orthopedics, LLC

Uncoated femoral stem prosthesis, one-piece

• Primary Device ID: 00880304008397
• NIH Device Record Key: 2f3918d1-d85b-4fb2-b3ad-c6ab46447c0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RX90 REVISION HIP SYSTEM
• Version Model Number: 129114
• Catalog Number: 129114
• 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	00880304008397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942028

FDA Product Code

• JDG: Prosthesis, hip, femoral component, cemented, metal

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: 2015-10-24

On-Brand Devices [RX90 REVISION HIP SYSTEM]

• 00880304226142: 129130
• 00880304226135: 129129
• 00880304226128: 129128
• 00880304226104: 129127
• 00880304226098: 129126
• 00880304226074: 129125
• 00880304226067: 129124
• 00880304226050: 129123
• 00880304226043: 129120
• 00880304226036: 129119
• 00880304226029: 129118
• 00880304226012: 129117
• 00880304225992: 129116
• 00880304225985: 129115
• 00880304225961: 129113
• 00880304008397: 129114