X-FIX 09590

GUDID 00887868084447

Biomet Orthopedics, LLC

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

• Primary Device ID: 00887868084447
• NIH Device Record Key: 88a2d20a-edec-4ece-9b78-d9af01292a8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-FIX
• Version Model Number: 09590
• Catalog Number: 09590
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00887868084447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020403

FDA Product Code

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

Sterilization

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

[00887868084447]

Moist Heat or Steam Sterilization

[00887868084447]

Moist Heat or Steam Sterilization

[00887868084447]

Moist Heat or Steam Sterilization

[00887868084447]

Moist Heat or Steam Sterilization

[00887868084447]

Moist Heat or Steam Sterilization

[00887868084447]

Moist Heat or Steam Sterilization

[00887868084447]

Moist Heat or Steam Sterilization

[00887868084447]

Moist Heat or Steam Sterilization

[00887868084447]

Moist Heat or Steam Sterilization

[00887868084447]

Moist Heat or Steam Sterilization

[00887868084447]

Moist Heat or Steam Sterilization

[00887868084447]

Moist Heat or Steam Sterilization

[00887868084447]

Moist Heat or Steam Sterilization

[00887868084447]

Moist Heat or Steam Sterilization

[00887868084447]

Moist Heat or Steam Sterilization

[00887868084447]

Moist Heat or Steam Sterilization

[00887868084447]

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: 2016-10-28

Devices Manufactured by Biomet Orthopedics, LLC

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• 08428898885684 - BIPASS DISPOSABLE PUSHER: 2024-09-11
• 08428898885691 - BIPASS DISPOSABLE PUSHER: 2024-09-11
• 00880304338548 - AGC ANTERIOR FILE: 2024-09-11
• 00880304339224 - PARALLEL PULLER: 2024-09-11
• 00880304342187 - AGC MODULAR TIBIAL II: 2024-09-11
• 00880304365247 - BIO-MODULAR: 2024-09-11
• 00880304368637 - BOHN MODULAR FEMORAL STEM EXTRACTOR: 2024-09-11