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Evolve

FDA UDI

Class I (US FDA UDI)

by Wright Medical Technology, Inc.

Identity

Trade Name
EVOLVE FDA UDI
Generic Name
Orthopaedic implant/instrument assembling device FDA UDI
Device Name
Proline Head Paddle FDA UDI
Model / Reference
24991022 FDA UDI
Description
Proline Head Paddle FDA UDI

Identifiers

Catalog Number
24991022 FDA UDI
Primary DI / UDI-DI
00840420191663 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic implant/instrument assembling device FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

Category: Orthopaedic implant/instrument assembling device

The Proline Head Paddle is a non-sterile, reusable orthopaedic implant/instrument assembling device designed to support the assembly of component parts of an orthopaedic surgical procedure. It is available in one form and intended for single-use use.

Similar devices

Also classified as Orthopaedic implant/instrument assembling device.

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 afff2546-3ec0-4d94-bf73-c3398c3cea1b 36 fields · synced Jul 10, 2026