FDA.reportPublic FDA data

Inion OTPS Pin Instruments

Primary DI
M224INS92309
Brand
Inion OTPS Pin Instruments
Company
Inion Oy
Model
1
Catalog number
INS-9230
Device description
Pin applicator 1.5 mm
Published
2020-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
06438408004698PrimaryGS10
M224INS92309SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438408004698064384080046986438408004698

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
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
06438408004520Inion 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
M224INS92319Inion OTPS Pin InstrumentsInion OyHXJ2020-05-08
M224INS928020Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
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