INFINITY™ EVERLAST™

GUDID 00889797074544

WRIGHT MEDICAL TECHNOLOGY, INC.

Fixed-bearing total ankle prosthesis

• Primary Device ID: 00889797074544
• NIH Device Record Key: d32e688f-3783-4fe1-82ef-dd7af4bc2ca9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INFINITY™ EVERLAST™
• Version Model Number: 33683312
• 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
• 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

• Height: 12 Millimeter
• Device Size Text, specify: 0
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Height: 12 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889797074544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193067

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-15
• Device Publish Date: 2020-07-07

On-Brand Devices [INFINITY™ EVERLAST™]

• 00889797074704: 33685512
• 00889797074698: 33685510
• 00889797074681: 33685508
• 00889797074674: 33685506
• 00889797074667: 33685413
• 00889797074650: 33685411
• 00889797074643: 33685409
• 00889797074636: 33685407
• 00889797074629: 33684412
• 00889797074612: 33684410
• 00889797074605: 33684408
• 00889797074599: 33684406
• 00889797074582: 33684313
• 00889797074575: 33684311
• 00889797074568: 33684309
• 00889797074551: 33684307
• 00889797074544: 33683312
• 00889797074537: 33683310
• 00889797074520: 33683308
• 00889797074513: 33683306
• 00889797074506: 33683212
• 00889797074490: 33683210
• 00889797074483: 33683208
• 00889797074476: 33683206
• 00889797074469: 33682212
• 00889797074452: 33682210
• 00889797074445: 33682208
• 00889797074438: 33682206
• 00889797074384: 33681112
• 00889797074377: 33681110
• 00889797074360: 33681108
• 00889797074353: 33681106