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: Implantable bone washer FDA UDI
Device Name: 5.0MM HEADED FLAT WASHER FDA UDI
Model / Reference: OS911000-NS FDA UDI
Description: 5.0MM HEADED FLAT WASHER FDA UDI

Identifiers

Catalog Number: OS911000-NS FDA UDI
Primary DI / UDI-DI: 05055662918335 FDA UDI
510(k) Number: K163489 FDA UDI
FDA Product Code: NDG FDA UDI
GMDN Term: Implantable bone washer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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: Implantable bone washer

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

Similar devices

Also classified as Implantable bone washer.

ISOLA — Depuy Spine, Inc. · Class II
Spiked Gridlock Screw Washer — Trilliant Surgical LLC · Class II
Monster Screw System — Paragon 28 · Class II
ALPHALOK Plating System — Vilex, Inc. · Class II
Monster Screw System — Paragon 28 · Class II
FLAT WASHER — Biomet Orthopedics, Inc. · Class II
Fixcet Spinal Facet Screw System — Xtant Medical Holdings, Inc. · U
LEOS Cannulated Screw System — Tyber Medical · Class II

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 2045c011-3bbf-458b-8132-52f0f35653ad 36 fields · synced Jun 8, 2026