ORTHOXEL DESIGNATED ACTIVITY COMPANY

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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

Rod, Fixation, Intramedullary And Accessories (HSB) (10)

Premarket Exempt

No Yes

Clear

Apex - 05391529587529 Catalog Number : F04-145280

Device Description : Apex Femoral Nail GT Right Ø 14.5 x 280mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529587536 Catalog Number : F04-145300

Device Description : Apex Femoral Nail GT Right Ø 14.5 x 300mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529587543 Catalog Number : F04-145320

Device Description : Apex Femoral Nail GT Right Ø 14.5 x 320mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529587550 Catalog Number : F04-145340

Device Description : Apex Femoral Nail GT Right Ø 14.5 x 340mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529587567 Catalog Number : F04-145360

Device Description : Apex Femoral Nail GT Right Ø 14.5 x 360mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529587574 Catalog Number : F04-145380

Device Description : Apex Femoral Nail GT Right Ø 14.5 x 380mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529587581 Catalog Number : F04-145400

Device Description : Apex Femoral Nail GT Right Ø 14.5 x 400mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529587598 Catalog Number : F04-145420

Device Description : Apex Femoral Nail GT Right Ø 14.5 x 420mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529587604 Catalog Number : F04-145440

Device Description : Apex Femoral Nail GT Right Ø 14.5 x 440mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529587611 Catalog Number : F04-145460

Device Description : Apex Femoral Nail GT Right Ø 14.5 x 460mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

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