FDA.reportPublic FDA data

Inion FreedomPin Instruments

Primary DI
06438408004520
Brand
Inion FreedomPin Instruments
Company
Inion Oy
Model
1
Catalog number
INS-9285
Device description
Applicator 2.7 mm
Published
2020-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
06438408004520PrimaryGS10
M224INS92859SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438408004520064384080045206438408004520

GMDN Terms#

Term, Definition table
TermDefinition
Bone tack inserter, basicA hand-held manual surgical instrument designed to drive (insert) a tack into bone, typically to fixate an orthopaedic plate or sheet. It is typically formed with a shaft made of high-grade stainless steel and a handle at the proximal end made of metal or synthetic material. The distal end is designed to hold (grip) the head of the tack head during insertion, typically through a hole in the plate or sheet and into a pre-drilled hole in the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
367994657
Device count
1
Premarket exempt
true
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

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
05055662969788COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXJ2024-04-01
06438408004452Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
06438408004551Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
06438408004698Inion OTPS Pin InstrumentsInion OyHXJ2020-05-08
06438408004704Inion OTPS Pin InstrumentsInion OyHXJ2020-05-08
06438408007293Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
M224INS92819Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
M224INS92859Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
M224INS92889Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
M224INS92309Inion OTPS Pin InstrumentsInion OyHXJ2020-05-08
M224INS92319Inion OTPS Pin InstrumentsInion OyHXJ2020-05-08
M224INS928020Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
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