INFINITY

GUDID 00840420122445

WRIGHT MEDICAL TECHNOLOGY, INC.

Mobile-bearing total ankle prosthesis

• Primary Device ID: 00840420122445
• NIH Device Record Key: 7a47a94b-91b6-4efc-8de5-059253ff4e1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INFINITY
• Version Model Number: 33636606
• 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

Device Dimensions

• Height: 6 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420122445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123954

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-01

On-Brand Devices [INFINITY]

• 00889797006477: 33620136
• 00889797006460: 33620135
• 00889797006453: 33620134
• 00889797006446: 33620133
• 00889797006439: 33620132
• 00889797004862: 33600191
• 00889797004855: 33600190
• 00889797004794: 33600170
• 00889797004640: 33600136
• 00889797004633: 33600135
• 00889797004626: 33600134
• 00889797004619: 33600133
• 00889797004602: 33600132
• 00889797006217: 33609034
• 00889797004848: 33600176
• 00889797004831: 33600175
• 00889797004824: 33600174
• 00889797004817: 33600173
• 00889797004800: 33600172
• 00889797004787: 33600166
• 00889797004770: 33600165
• 00889797004763: 33600164
• 00889797004756: 33600163
• 00889797004749: 33600162
• 00889797004732: 33600161
• 00889797003971: 33600025
• 00840420122971: 33656612
• 00840420122964: 33656610
• 00840420122957: 33656608
• 00840420122940: 33656606
• 00840420122933: 33656513
• 00840420122926: 33656511
• 00840420122919: 33656509
• 00840420122902: 33656507
• 00840420122896: 33655512
• 00840420122889: 33655510
• 00840420122872: 33655508
• 00840420122865: 33655506
• 00840420122858: 33655413
• 00840420122841: 33655411
• 00840420122834: 33655409
• 00840420122827: 33655407
• 00840420122810: 33654412
• 00840420122803: 33654410
• 00840420122797: 33654408
• 00840420122780: 33654406
• 00840420122773: 33654313
• 00840420122766: 33654311
• 00840420122759: 33654309
• 00840420122742: 33654307