X FIX 09580

GUDID 00887868084423

Biomet Orthopedics, LLC

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

• Primary Device ID: 00887868084423
• NIH Device Record Key: 4d54d83d-0550-43de-98e8-b364e5872fd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X FIX
• Version Model Number: 09580
• Catalog Number: 09580
• 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	00887868084423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981483

FDA Product Code

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

Sterilization

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

[00887868084423]

Moist Heat or Steam Sterilization

[00887868084423]

Moist Heat or Steam Sterilization

[00887868084423]

Moist Heat or Steam Sterilization

[00887868084423]

Moist Heat or Steam Sterilization

[00887868084423]

Moist Heat or Steam Sterilization

[00887868084423]

Moist Heat or Steam Sterilization

[00887868084423]

Moist Heat or Steam Sterilization

[00887868084423]

Moist Heat or Steam Sterilization

[00887868084423]

Moist Heat or Steam Sterilization

[00887868084423]

Moist Heat or Steam Sterilization

[00887868084423]

Moist Heat or Steam Sterilization

[00887868084423]

Moist Heat or Steam Sterilization

[00887868084423]

Moist Heat or Steam Sterilization

[00887868084423]

Moist Heat or Steam Sterilization

[00887868084423]

Moist Heat or Steam Sterilization

[00887868084423]

Moist Heat or Steam Sterilization

[00887868084423]

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

On-Brand Devices [X FIX]

• 00887868081750: 03065
• 00888480105251: 03165
• 00887868084430: 09585
• 00887868084423: 09580
• 00887868083556: 06187
• 00887868083532: 06182
• 00887868083518: 06177
• 00887868083280: 05060
• 00887868082047: 03190
• 00888480111450: 06172
• 00888480109235: 05070
• 00888480105534: 03200
• 00888480105459: 03191
• 00888480105398: 03187
• 00888480105275: 03170
• 00888480105121: 03148
• 00888480105114: 03145
• 00888480105053: 03135
• 00888480104957: 03120
• 00887868089978: 13180
• 00887868084348: 07130
• 00887868084331: 07129
• 00887868084324: 07128
• 00887868084317: 07125
• 00887868084300: 07120
• 00887868084256: 07100
• 00887868083624: 06258
• 00887868083310: 05125
• 00887868083303: 05080
• 00887868083273: 05045
• 00887868083266: 05040
• 00887868083242: 05030
• 00887868083235: 05025
• 00887868083228: 05021
• 00887868083211: 05020
• 00887868082603: 04490
• 00887868082580: 04480
• 00887868082122: 03235
• 00887868082009: 03180
• 00887868081927: 03160
• 00887868081880: 03155
• 00887868081859: 03111
• 00887868081828: 03100
• 00887868081811: 03095
• 00887868081804: 03090
• 00887868081798: 03085
• 00887868081781: 03080
• 00887868081774: 03075
• 00887868081767: 03070
• 00887868081743: 03060