MAXIM ACCEL KNEE SYSTEM RD255012

GUDID 00880304649477

Biomet Orthopedics, LLC

Uncoated knee femur prosthesis, metallic

• Primary Device ID: 00880304649477
• NIH Device Record Key: 5f22cc7d-545b-4ba9-9c85-e977f9a1cca3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAXIM ACCEL KNEE SYSTEM
• Version Model Number: RD255012
• Catalog Number: RD255012
• 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	00880304649477 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023546

FDA Product Code

• 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: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-10-24

On-Brand Devices [MAXIM ACCEL KNEE SYSTEM]

• 00880304849211: SSI003712
• 00880304849204: SSI003711
• 00880304849198: SSI003710
• 00880304849181: SSI003709
• 00880304849174: SSI003708
• 00880304849167: SSI003707
• 00880304649484: RD255013
• 00880304649477: RD255012
• 00880304649460: RD255011
• 00880304649453: RD255008
• 00880304649422: RD255004