Valencia Pedicle Screw System

FDA UDI

Class II (US FDA UDI)

by Altus Spine

Identity

Trade Name: Valencia Pedicle Screw System FDA UDI
Generic Name: Orthopaedic guidewire, single-use FDA UDI
Device Name: 480mm Guide Wire, Round Tip, Nitinol FDA UDI
Model / Reference: 909-0480NT FDA UDI
Description: 480mm Guide Wire, Round Tip, Nitinol FDA UDI

Identifiers

Primary DI / UDI-DI: 00843210121765 FDA UDI
FDA Product Code: MNI FDA UDI
KWP FDA UDI
MNH FDA UDI
NKB FDA UDI
KWQ FDA UDI
GMDN Term: Orthopaedic guidewire, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
888.3050 FDA UDI
888.3060 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

Yes

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 480 Millimeter FDA UDI

Category: Orthopaedic guidewire, single-use

Valencia Pedicle Screw System by Altus Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic guidewire, single-use.

OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP. · Class II
Gen II Cannulated Screws — ORTHOPEDIATRICS CORP. · Class II
Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
2.7mm Guidewire, Drill Tip, 300mm — OsteoCentric Technologies,Inc · Class I
Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
Ball Tip Wire — Orthopedic Designs North America, Inc. · Class I
HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC · Class I

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 II	Pending data

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Manufacturer

Manufacturer: Altus Spine

Sources (1)

FDA UDI 2b460a30-99b2-464d-b068-85db080b9f71 35 fields · synced May 31, 2026