Volition Plating System

FDA UDI

Class I (US FDA UDI)

by Ortho Solutions Holdings Limited

Identity

Trade Name: Volition Plating System FDA UDI
Generic Name: Surgical countersink, single-use FDA UDI
Device Name: COUNTERSINK FOR 3.5MM HEADLESS SCREW CANNULATED AO QC FDA UDI
Model / Reference: OS741300-NS FDA UDI
Description: COUNTERSINK FOR 3.5MM HEADLESS SCREW CANNULATED AO QC FDA UDI

Identifiers

Catalog Number: OS741300-NS FDA UDI
Primary DI / UDI-DI: 05055662967579 FDA UDI
510(k) Number: K163489 FDA UDI
FDA Product Code: HWW FDA UDI
GMDN Term: Surgical countersink, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

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: Surgical countersink, single-use

Volition Plating System by Ortho Solutions Holdings Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical countersink, single-use.

GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class I
VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc. · Class II
CrossRoads Screw System — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
BITE COMPRESSION SCREWS — Orthofix, Inc. · Class II
VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc. · Class II
FuzeFix Mini — FUSION ORTHOPEDICS, LLC · Class II
Healix — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class I
Dyna Locking Cannulated Screw — CG MedTech Co., Ltd. · Class I

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 I	Pending data

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

Manufacturer

Manufacturer: Ortho Solutions Holdings Limited

Sources (1)

FDA UDI edcc1708-7041-43bc-a03a-39f3fd344dfa 35 fields · synced Jun 6, 2026