Volition Plating System

FDA UDI

Class II (US FDA UDI)

by Ortho Solutions Holdings Limited

Identity

Trade Name: Volition Plating System FDA UDI
Generic Name: Implantable bone washer FDA UDI
Device Name: WASHER FOR 3.5MM HEADED CANN. SCREW FDA UDI
Model / Reference: OS740100-NS FDA UDI
Description: WASHER FOR 3.5MM HEADED CANN. SCREW FDA UDI

Identifiers

Catalog Number: OS740100-NS FDA UDI
Primary DI / UDI-DI: 05055662967555 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

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

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

Volition Plating System 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Ortho Solutions Holdings Limited

Sources (1)

FDA UDI 0566c3a2-74b7-4ce4-8633-1ac6aa20b0a9 35 fields · synced May 30, 2026