CONSTRUX EXTERNAL FIXATION SYSTEM 14-450540

GUDID 00887868099779

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: 00887868099779
• NIH Device Record Key: 6950dc37-21b5-4e2e-bf48-0217c1bc5c5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONSTRUX EXTERNAL FIXATION SYSTEM
• Version Model Number: 14-450540
• Catalog Number: 14-450540
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00887868099779 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111376

FDA Product Code

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

Sterilization

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

[00887868099779]

Moist Heat or Steam Sterilization

[00887868099779]

Moist Heat or Steam Sterilization

[00887868099779]

Moist Heat or Steam Sterilization

[00887868099779]

Moist Heat or Steam Sterilization

[00887868099779]

Moist Heat or Steam Sterilization

[00887868099779]

Moist Heat or Steam Sterilization

[00887868099779]

Moist Heat or Steam Sterilization

[00887868099779]

Moist Heat or Steam Sterilization

[00887868099779]

Moist Heat or Steam Sterilization

[00887868099779]

Moist Heat or Steam Sterilization

[00887868099779]

Moist Heat or Steam Sterilization

[00887868099779]

Moist Heat or Steam Sterilization

[00887868099779]

Moist Heat or Steam Sterilization

[00887868099779]

Moist Heat or Steam Sterilization

[00887868099779]

Moist Heat or Steam Sterilization

[00887868099779]

Moist Heat or Steam Sterilization

[00887868099779]

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 [CONSTRUX EXTERNAL FIXATION SYSTEM]

• 00880304504738: 01800
• 00888480103530: 01915
• 00887868099786: 14-450545
• 00887868099779: 14-450540
• 00887868099762: 14-450535
• 00887868099755: 14-450530
• 00887868099748: 14-450525
• 00887868099731: 14-450520
• 00887868099724: 14-450515
• 00887868099717: 14-450510
• 00887868099700: 14-450505
• 00887868099656: 14-450500
• 00887868081095: 01920
• 00887868081071: 01820
• 00887868081064: 01810
• 00887868081057: 01805
• 00887868081040: 01801