INFINITY™ 33680024

GUDID 00889797101530

WRIGHT MEDICAL TECHNOLOGY, INC.

Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis

• Primary Device ID: 00889797101530
• NIH Device Record Key: c375a8dd-70f4-427b-89ef-9a6771056c54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INFINITY™
• Version Model Number: 33680024
• Catalog Number: 33680024
• Company DUNS: 807201207
• Company Name: WRIGHT MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00889797101530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172633

FDA Product Code

• HSN: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-09
• Device Publish Date: 2022-06-01

On-Brand Devices [INFINITY™]

• 00889797101554: 33680025
• 00889797101547: 33680023
• 00889797101530: 33680024
• 00889797101523: 33680022
• 00889797101516: 33680021