Volition Plating System

Basic Information

• Brand Name: Volition Plating System
• Primary DI: 05055662967555
• Version / Model: OS740100-NS
• Catalog Number: OS740100-NS
• Company Name: ORTHO SOLUTIONS HOLDINGS LIMITED
• Labeler DUNS: 218648211
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-25
• Public Version: 2
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 0566c3a2-74b7-4ce4-8633-1ac6aa20b0a9

Device Description

WASHER FOR 3.5MM HEADED CANN. SCREW

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDG	Washer, Bolt, Nut, Non-Spinal, Metallic	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61670	Implantable bone washer	An implantable, flat ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic, spinal, and/or craniofacial bone fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055662967555	GS1

Premarket Submissions

Submission Number	Supplement Number
K163489	000