Maxim Accel Knee System SSI003711

GUDID 00880304849204

Biomet Orthopedics, LLC

Knee tibia prosthesis trial

• Primary Device ID: 00880304849204
• NIH Device Record Key: 083e1035-ed77-419b-b470-9a3849b3944e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maxim Accel Knee System
• Version Model Number: SSI003711
• Catalog Number: SSI003711
• 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
• 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

• Height: 11 Millimeter
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304849204 [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: true
• Device Is Sterile: false

[00880304849204]

Moist Heat or Steam Sterilization

[00880304849204]

Moist Heat or Steam Sterilization

[00880304849204]

Moist Heat or Steam Sterilization

[00880304849204]

Moist Heat or Steam Sterilization

[00880304849204]

Moist Heat or Steam Sterilization

[00880304849204]

Moist Heat or Steam Sterilization

[00880304849204]

Moist Heat or Steam Sterilization

[00880304849204]

Moist Heat or Steam Sterilization

[00880304849204]

Moist Heat or Steam Sterilization

[00880304849204]

Moist Heat or Steam Sterilization

[00880304849204]

Moist Heat or Steam Sterilization

[00880304849204]

Moist Heat or Steam Sterilization

[00880304849204]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2017-01-27

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