Inion Oy

Address:LAAKARINKATU 2,TAMPERE Pirkanmaa,FI

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Screw, fixation, bone (HWC) (8) Fastener, fixation, biodegradable, soft tissue (MAI) (1) PLATE, BONE (JEY) (1) Resorbable spinal intervertebral body fixation orthosis - plate (OJB) (1) Staple, fixation, bone (JDR) (1)

Premarket Exempt

No Yes

Clear

1.5 mm Inion CPS® Baby - M224SCR22209 Catalog Number : SCR-2220

Device Description : 1.5 x 4 mm screw

Device Class :

Duns Number: 367994657

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

1.5 mm Inion CPS® Baby - M224SCR22219 Catalog Number : SCR-2221

Device Description : 1.5 x 6 mm screw

Device Class :

Duns Number: 367994657

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

1.5 mm Inion CPS® Baby - M224SCR22229 Catalog Number : SCR-2222

Device Description : 1.5 x 4 mm screw

Device Class :

Duns Number: 367994657

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

1.5 mm Inion CPS® Baby - M224SCR22239 Catalog Number : SCR-2223

Device Description : 1.5 x 6 mm screw

Device Class :

Duns Number: 367994657

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

2.0 mm Inion CPS® Baby - M224SCR22249 Catalog Number : SCR-2224

Device Description : 2.0 x 5 mm screw

Device Class :

Duns Number: 367994657

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

2.0 mm Inion CPS® Baby - M224SCR22259 Catalog Number : SCR-2225

Device Description : 2.0 x 7 mm screw

Device Class :

Duns Number: 367994657

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Inion Trinion™ - M224SET30029 Catalog Number : SET-3002

Device Description : 10 mm (x3) meniscus screw

Device Class :

Duns Number: 367994657

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Inion Hexalon™ - M224SET40009 Catalog Number : SET-4000

Device Description : ACL/PCL screw 7x25, 8x25, 8x30, 9x30 mm

Device Class :

Duns Number: 367994657

Premarket Exempt : No

Product Code : JDR, HWC, MAI

Prescription Use : Yes

Device Count : 1

2.0 mm Inion CPS® - M224SOP10339 Catalog Number : SOP-1033

Device Description : 90 x 90 x 0.6 mm Solid Sheet

Device Class :

Duns Number: 367994657

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

Inion S-1™ - M224SPN50009 Catalog Number : SPN-5000

Device Description : Plate, 25 x 19 x 2.0 mm

Device Class : 2

Duns Number: 367994657

Premarket Exempt : No

Product Code : OJB

Prescription Use : Yes

Device Count : 1

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