ANCHORAGE SYSTEM SP-3006

GUDID 00841036163877

BIOMET MICROFIXATION, INC

Orthodontic anchor plate

• Primary Device ID: 00841036163877
• NIH Device Record Key: 0176ed9a-d6b7-4e97-9eaf-a0ba9cdb1715
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANCHORAGE SYSTEM
• Version Model Number: SP-3006
• Catalog Number: SP-3006
• Company DUNS: 046189866
• Company Name: BIOMET MICROFIXATION, INC
• 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: 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(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036163877 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063386

FDA Product Code

• OAT: Implant, endosseous, orthodontic

Sterilization

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

[00841036163877]

Moist Heat or Steam Sterilization

[00841036163877]

Moist Heat or Steam Sterilization

[00841036163877]

Moist Heat or Steam Sterilization

[00841036163877]

Moist Heat or Steam Sterilization

[00841036163877]

Moist Heat or Steam Sterilization

[00841036163877]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-11

On-Brand Devices [ANCHORAGE SYSTEM]

• 00841036163891: SP-3008
• 00841036163884: SP-3007
• 00841036163877: SP-3006
• 00841036163860: SP-3005
• 00841036163853: SP-3004
• 00841036163846: SP-3003
• 00841036133368: SP-2034
• 00841036133351: SP-2033
• 00841036129903: SP-2106
• 00841036129897: SP-2107