FDA.reportPublic FDA data

Volition™ Plating System

Primary DI
05055662966343
Brand
Volition™ Plating System
Company
ORTHO SOLUTIONS HOLDINGS LIMITED
Model
OS292220-NS
Catalog number
OS292220-NS
Device description
K-WIRE TROCAR TIP 2.0MM X 200MM
Published
2021-06-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYTFixation Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYTFixation AccessoryOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202764000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202764000Ortho Solutions Plating SystemOrtho Solutions UK , Ltd.2020-11-20HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055662966343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055662966343050556629663435055662966343

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+441621843599quality@orthosol.com

Regulatory Flags#

DUNS number
218648211
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055662969641ORTHO SOLUTIONS VOLITION PLATING SYSTEMOS720012OS720012-NS2023-10-31
05055662969474ORTHO SOLUTIONS VOLITION PLATING SYSTEMOS733114LOS733114L-NS2023-03-17
05055662976649Volition™ Plating SystemOS731052R-NSOS731052R-NS2026-10-06
05055662976656Volition™ Plating SystemOS731052L-NSOS731052L-NS2026-10-06
05055662976663Volition™ Plating SystemOS731043-NSOS731043-NS2026-10-06
05055662976670Volition™ Plating SystemOS731022R-NSOS731022R-NS2026-10-06
05055662976687Volition™ Plating SystemOS731022L-NSOS731022L-NS2026-10-06
05055662963489Volition™ Plating SystemOS731051R-NSOS731051R-NS2021-06-25
05055662963496Volition™ Plating SystemOS731051L-NSOS731051L-NS2021-06-25
05055662971057ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353017-NSOS353017-NS2025-08-15
05055662970890ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS355038-SOS355038-S2026-07-10
05055662971514ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356075-SOS356075-S2026-07-10
05055662968545OrthoSolutions 'System26' Bone ScrewsOS900106-NSOS900106-NS2026-06-24
05055662971361ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353018-NSOS353018-NS2026-04-09
05055662971378ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353103-SOS353103-S2026-04-09
05055662971385ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353103L-SOS353103L-S2026-04-09
05055662971392ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353104-SOS353104-S2026-04-09
05055662971408ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353113-SOS353113-S2026-04-09
05055662971415ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS355055-SOS355055-S2026-04-09
05055662971422ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS355060-SOS355060-S2026-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055662968408Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDLYT2022-11-28
05055662963182Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDLYT2021-06-25
05690977084254Halo SystemsOSSUR AMERICAS, INC.LYT2018-05-16
05690977084490Halo SystemsOSSUR AMERICAS, INC.LYT2018-05-16
05690977084544Halo SystemsOSSUR AMERICAS, INC.LYT2018-05-16
05690977192577Halo SystemsOSSUR AMERICAS, INC.LYT2018-05-16
05690977194090Halo SystemsOSSUR AMERICAS, INC.LYT2018-05-16
05690977368965Halo SystemsOSSUR AMERICAS, INC.LYT2018-05-16
04546540568083Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
04546540568090Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
04546540568106Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
04546540568113Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
04546540568120Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
04546540568137Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
04546540568144Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
04546540568151Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
04546540568168Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613154490240Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613154490257Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613154490264Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613154490271Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613154490288Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613154490295Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613154490301Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613154490318Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613154490325Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613327013306Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613327013313Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613327013320Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24
07613327013337Dall-MilesHowmedica Osteonics Corp.LYT2015-09-24