EVOLVE ORTHOLOC

GUDID 00840420125934

WRIGHT MEDICAL TECHNOLOGY, INC.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00840420125934
• NIH Device Record Key: 1fbe57ee-27f8-4bc3-948c-ac31c0625e85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVOLVE ORTHOLOC
• Version Model Number: 4953112L
• Company DUNS: 807201207
• Company Name: WRIGHT MEDICAL TECHNOLOGY, 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: true
• Expiration Date: true
• 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)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420125934 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100146

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00840420125934]

Moist Heat or Steam Sterilization

[00840420125934]

Moist Heat or Steam Sterilization

[00840420125934]

Moist Heat or Steam Sterilization

[00840420125934]

Moist Heat or Steam Sterilization

[00840420125934]

Moist Heat or Steam Sterilization

[00840420125934]

Moist Heat or Steam Sterilization

[00840420125934]

Moist Heat or Steam Sterilization

[00840420125934]

Moist Heat or Steam Sterilization

[00840420125934]

Moist Heat or Steam Sterilization

[00840420125934]

Moist Heat or Steam Sterilization

[00840420125934]

Moist Heat or Steam Sterilization

[00840420125934]

Moist Heat or Steam Sterilization

[00840420125934]

Moist Heat or Steam Sterilization

[00840420125934]

Moist Heat or Steam Sterilization

[00840420125934]

Moist Heat or Steam Sterilization

[00840420125934]

Moist Heat or Steam Sterilization

[00840420125934]

Moist Heat or Steam Sterilization

[00840420125934]

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: 2015-10-01

On-Brand Devices [EVOLVE ORTHOLOC]

• 00840420126030: 495414RL
• 00840420126023: 495413RL
• 00840420126016: 495411RL
• 00840420126009: 495410RL
• 00840420125996: 495319RL
• 00840420125989: 495318RL
• 00840420125972: 495316RL
• 00840420125965: 495315RL
• 00840420125958: 495312RL
• 00840420125941: 4953112R
• 00840420125934: 4953112L
• 00840420125927: 4953111R
• 00840420125910: 4953111L
• 00840420125903: 4953110R
• 00840420125897: 4953110L
• 00840420125880: 4953109R
• 00840420125873: 4953109L
• 00840420125866: 4953108R
• 00840420125859: 4953108L
• 00840420125842: 4953107R
• 00840420125835: 4953107L
• 00840420125828: 4953106R
• 00840420125811: 4953106L
• 00840420125804: 4953105R
• 00840420125798: 4953105L