FDA.reportPublic FDA data

Inion S-2 instrument

Primary DI
M224INS95819
Brand
Inion S-2 instrument
Company
Inion Oy
Model
0
Catalog number
INS-9581
Device description
Temporary fixation screw
Published
2016-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OJBResorbable spinal intervertebral body fixation orthosis - plate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJBResorbable Spinal Intervertebral Body Fixation Orthosis - PlateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071810000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071810000INION SPINAL GRAFT CONTAINMENT SYSTEMInion , Ltd.2008-07-11OJB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M224INS95819PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation implant alignment toolA surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
367994657
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438408012587Inion® Universal instruments2INS-90912026-05-11
06438408012037Inion Hexalon instrument2INS-92002026-05-06
06438408002397Inion Hexalon™ ACL/PCL Screw1ACL-41132022-08-26
06438408002403Inion Hexalon™ ACL/PCL Screw1ACL-41142022-08-26
06438408002410Inion Hexalon™ ACL/PCL Screw1ACL-41152022-08-26
06438408002427Inion Hexalon™ ACL/PCL Screw1ACL-41012022-08-26
06438408002434Inion Hexalon™ ACL/PCL Screw1ACL-41022022-08-26
06438408002441Inion Hexalon™ ACL/PCL Screw1ACL-41032022-08-26
06438408002458Inion Hexalon™ ACL/PCL Screw1ACL-41042022-08-26
06438408002465Inion Hexalon™ ACL/PCL Screw1ACL-41052022-08-26
06438408002472Inion Hexalon™ ACL/PCL Screw1ACL-41062022-08-26
06438408002489Inion Hexalon™ ACL/PCL Screw1ACL-41072022-08-26
06438408002496Inion Hexalon™ ACL/PCL Screw1ACL-41082022-08-26
06438408002502Inion Hexalon™ ACL/PCL Screw1ACL-41092022-08-26
06438408002519Inion Hexalon™ ACL/PCL Screw1ACL-41122022-08-26
06438408012181Inion S-1™1SPN-50042023-12-19
06438408012198Inion S-1™1SPN-50052023-12-19
06438408012204Inion S-1™1SPN-50062023-12-19
06438408012211Inion S-1™1SPN-50072023-12-19
06438408012099Inion CPS™ instrumentation1INS-92752026-01-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06438408006883Inion S-1™Inion OyOJB2023-12-19
06438408007019Inion S-2™Inion OyOJB2023-12-19
06438408007026Inion S-2™Inion OyOJB2023-12-19
06438408007033Inion S-2™Inion OyOJB2023-12-19
06438408007156Inion S-2™Inion OyOJB2023-12-19
06438408007163Inion S-2™Inion OyOJB2023-12-19
06438408012143Inion S-1™Inion OyOJB2023-12-19
06438408012150Inion S-1™Inion OyOJB2023-12-19
06438408012167Inion S-1™Inion OyOJB2023-12-19
06438408012174Inion S-1™Inion OyOJB2023-12-19
06438408012181Inion S-1™Inion OyOJB2023-12-19
06438408012198Inion S-1™Inion OyOJB2023-12-19
06438408012204Inion S-1™Inion OyOJB2023-12-19
06438408012211Inion S-1™Inion OyOJB2023-12-19
06438408012228Inion S-1™Inion OyOJB2023-12-19
06438408012235Inion S-1™Inion OyOJB2023-12-19
06438408012242Inion S-1™Inion OyOJB2023-12-19
06438408012259Inion S-1™Inion OyOJB2023-12-19
06438408012266Inion S-1™Inion OyOJB2023-12-19
06438408012273Inion S-1™Inion OyOJB2023-12-19
06438408012280Inion S-1™Inion OyOJB2023-12-19
06438408012297Inion S-1™Inion OyOJB2023-12-19
06438408012303Inion S-1™Inion OyOJB2023-12-19
06438408012310Inion S-2™Inion OyOJB2023-12-19
06438408012327Inion S-2™Inion OyOJB2023-12-19