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EVOLVE Proline

FDA UDI

Class I (US FDA UDI)

by Wright Medical Technology, Inc.

Identity

Trade Name
EVOLVE Proline FDA UDI
Generic Name
Elbow radius prosthesis trial FDA UDI
Device Name
Proline Modular Radial Head FDA UDI
Model / Reference
2496S475 FDA UDI
Description
Proline Modular Radial Head FDA UDI

Identifiers

Catalog Number
2496S475 FDA UDI
Primary DI / UDI-DI
00840420188588 FDA UDI
FDA Product Code
HWT FDA UDI
GMDN Term
Elbow radius prosthesis trial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 7.5 Millimeter FDA UDI

Category: Elbow radius prosthesis trial

EVOLVE Proline by Wright Medical Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Elbow radius prosthesis trial.

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 fd5b5848-dd4e-4b38-b90c-984ad7179666 36 fields · synced Jun 8, 2026