FDA.reportPublic FDA data

COGNiTiON™ Staple System

Primary DI
05055662969788
Brand
COGNiTiON™ Staple System
Company
ORTHO SOLUTIONS HOLDINGS LIMITED
Model
OS380913-NS
Device description
INSERTER 4 LEG X 25MM
Published
2024-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXJStaple Driver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXJStaple DriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055662969788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055662969788050556629697885055662969788

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055662922622Volition™ Plating SystemOS900091-NSOS900091-NS2026-10-16
05055662966855Volition™ Plating SystemOS720000A-NSOS720000A-NS2026-10-16
05055662966862Volition™ Plating SystemOS720000B-NSOS720000B-NS2026-10-16
05055662968538Volition™ Plating SystemOS740224-NSOS740224-NS2026-10-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760225718902In2BonesIN2BONESHXJ2024-12-13
05055662969733COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXJ2024-04-01
05055662969740COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXJ2024-04-01
05055662969757COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXJ2024-04-01
05055662969764COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXJ2024-04-01
05055662969771COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXJ2024-04-01
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M224INS92819Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
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M224INS92309Inion OTPS Pin InstrumentsInion OyHXJ2020-05-08
M224INS92319Inion OTPS Pin InstrumentsInion OyHXJ2020-05-08
M224INS928020Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
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