Whistler Modular Pedicle Screw System

FDA UDI

Class I (US FDA UDI)

by Evolution Spine, Llc

Identity

Trade Name: Whistler Modular Pedicle Screw System FDA UDI
Generic Name: Spinal guidewire FDA UDI
Device Name: K-WIRE NITINOL 1.4mm DIAMOND TIP 500 FDA UDI
Model / Reference: WI-013-D-500 FDA UDI
Description: K-WIRE NITINOL 1.4mm DIAMOND TIP 500 FDA UDI

Identifiers

Catalog Number: WI-013-D-500 FDA UDI
Primary DI / UDI-DI: 00195860023518 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Spinal guidewire 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 500 Millimeter FDA UDI

Category: Spinal guidewire

Whistler Modular Pedicle Screw System by Evolution Spine, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Evolution Spine, Llc

Sources (1)

FDA UDI 3e62b3ba-e2e9-4fe1-a6fa-714216d04e10 36 fields · synced Jun 8, 2026