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Infinity

FDA UDI

Class II (US FDA UDI)

by Wright Medical Technology, Inc.

Identity

Trade Name
INFINITY FDA UDI
Generic Name
Mobile-bearing total ankle prosthesis FDA UDI
Model / Reference
33656612 FDA UDI

Identifiers

Primary DI / UDI-DI
00840420122971 FDA UDI
510(k) Number
K140749 FDA UDI
FDA Product Code
HSN FDA UDI
GMDN Term
Mobile-bearing total ankle prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3110 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Height — 12 Millimeter FDA UDI

Category: Mobile-bearing total ankle prosthesis

Infinity by Wright Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mobile-bearing total ankle prosthesis.

Cleared under the same submission

K140749 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wright Medical Technology, Inc.

Sources (1)

  • FDA UDI 2159764b-25d5-4056-b028-159c44aab22f 35 fields · synced Jun 8, 2026