OrthoSolutions 'System26' Bone Screws

FDA UDI

Class II (US FDA UDI)

by Ortho Solutions Holdings Limited

Identity

Trade Name: OrthoSolutions 'System26' Bone Screws FDA UDI
Generic Name: Orthopaedic bone wire FDA UDI
Device Name: K-WIRE FOR 3.0MM SCREW SINGLE TROCAR 1.0 X 100MM (S/S 316 LVM) FDA UDI
Model / Reference: OS900088-NS FDA UDI
Description: K-WIRE FOR 3.0MM SCREW SINGLE TROCAR 1.0 X 100MM (S/S 316 LVM) FDA UDI

Identifiers

Catalog Number: OS900088-NS FDA UDI
Primary DI / UDI-DI: 05055662918694 FDA UDI
510(k) Number: K163489 FDA UDI
FDA Product Code: HTY FDA UDI
GMDN Term: Orthopaedic bone wire 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone wire

OrthoSolutions 'System26' Bone Screws by Ortho Solutions Holdings Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K163489 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: Ortho Solutions Holdings Limited

Sources (1)

FDA UDI 71fd2e8b-6641-4f7c-bc89-3dcc4fc03cda 36 fields · synced May 30, 2026