ACE-FISCHER ™STAINLESS STEEL THREADED ROD 101273040

GUDID 00887868010743

Biomet Orthopedics, LLC

External orthopaedic fixation system, single-use, non-sterile

• Primary Device ID: 00887868010743
• NIH Device Record Key: 1627d9d3-fe3b-4341-b501-6305143cad30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACE-FISCHER ™STAINLESS STEEL THREADED ROD
• Version Model Number: 1012-73-040
• Catalog Number: 101273040
• 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: 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
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868010743 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083789

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[00887868010743]

Moist Heat or Steam Sterilization

[00887868010743]

Moist Heat or Steam Sterilization

[00887868010743]

Moist Heat or Steam Sterilization

[00887868010743]

Moist Heat or Steam Sterilization

[00887868010743]

Moist Heat or Steam Sterilization

[00887868010743]

Moist Heat or Steam Sterilization

[00887868010743]

Moist Heat or Steam Sterilization

[00887868010743]

Moist Heat or Steam Sterilization

[00887868010743]

Moist Heat or Steam Sterilization

[00887868010743]

Moist Heat or Steam Sterilization

[00887868010743]

Moist Heat or Steam Sterilization

[00887868010743]

Moist Heat or Steam Sterilization

[00887868010743]

Moist Heat or Steam Sterilization

[00887868010743]

Moist Heat or Steam Sterilization

[00887868010743]

Moist Heat or Steam Sterilization

[00887868010743]

Moist Heat or Steam Sterilization

[00887868010743]

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: 2015-10-24

On-Brand Devices [ACE-FISCHER ™STAINLESS STEEL THREADED ROD]

• 00887868010743: 1012-73-040
• 00887868010736: 1012-73-035
• 00887868010729: 1012-73-030
• 00887868010712: 1012-73-025
• 00887868010705: 1012-73-020
• 00887868010699: 1012-73-015
• 00887868010682: 1012-73-010