K-Wire 0.9mm, Smooth, Single Trocar

FDA UDI

Class II (US FDA UDI)

by OsteoCentric Technologies, Inc

Identity

Trade Name: K-Wire 0.9mm, Smooth, Single Trocar FDA UDI
Generic Name: Orthopaedic guidewire, single-use FDA UDI
Device Name: K-Wire 0.9mm, Smooth, Single Trocar FDA UDI
Model / Reference: EX01-0026 FDA UDI
Description: K-Wire 0.9mm, Smooth, Single Trocar FDA UDI

Identifiers

Catalog Number: EX01-0026 FDA UDI
Primary DI / UDI-DI: 00850015496240 FDA UDI
510(k) Number: K200259 FDA UDI
FDA Product Code: HTY FDA UDI
GMDN Term: Orthopaedic guidewire, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 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

FDA UDI

Lot / Batch Number

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: Guidewire Diameter — 0.9 Millimeter FDA UDI

Category: Orthopaedic guidewire, single-use

K-Wire 0.9mm, Smooth, Single Trocar by OsteoCentric Technologies, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic guidewire, single-use.

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Gen II Cannulated Screws — ORTHOPEDIATRICS CORP. · Class II
Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · 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
Flower Orthopedics — FLOWER ORTHOPEDICS CORPORATION · Class I

Cleared under the same submission

K200259 also covers:

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: OsteoCentric Technologies, Inc

Sources (1)

FDA UDI 009a3d49-d36a-4af8-a97f-614632ca02e2 37 fields · synced Jun 8, 2026