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 - 05391529587321 Catalog Number : F04-120400

Device Description : Apex Femoral Nail GT Right Ø 12.0 x 400mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529587338 Catalog Number : F04-120420

Device Description : Apex Femoral Nail GT Right Ø 12.0 x 420mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529587345 Catalog Number : F04-120440

Device Description : Apex Femoral Nail GT Right Ø 12.0 x 440mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529587352 Catalog Number : F04-120460

Device Description : Apex Femoral Nail GT Right Ø 12.0 x 460mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529587369 Catalog Number : F04-120480

Device Description : Apex Femoral Nail GT Right Ø 12.0 x 480mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529587376 Catalog Number : F04-130240

Device Description : Apex Femoral Nail GT Right Ø 13.0 x 240mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529587383 Catalog Number : F04-130260

Device Description : Apex Femoral Nail GT Right Ø 13.0 x 260mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529587390 Catalog Number : F04-130280

Device Description : Apex Femoral Nail GT Right Ø 13.0 x 280mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529587406 Catalog Number : F04-130300

Device Description : Apex Femoral Nail GT Right Ø 13.0 x 300mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529587413 Catalog Number : F04-130320

Device Description : Apex Femoral Nail GT Right Ø 13.0 x 320mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

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