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 - 05391529581046 Catalog Number : F01-100340

Device Description : Apex Femoral Nail PF Left Ø 10.0 x 340mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529581053 Catalog Number : F01-100360

Device Description : Apex Femoral Nail PF Left Ø 10.0 x 360mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529581060 Catalog Number : F01-100380

Device Description : Apex Femoral Nail PF Left Ø 10.0 x 380mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529581077 Catalog Number : F01-100400

Device Description : Apex Femoral Nail PF Left Ø 10.0 x 400mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529581084 Catalog Number : F01-100420

Device Description : Apex Femoral Nail PF Left Ø 10.0 x 420mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529581091 Catalog Number : F01-100440

Device Description : Apex Femoral Nail PF Left Ø 10.0 x 440mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529581107 Catalog Number : F01-100460

Device Description : Apex Femoral Nail PF Left Ø 10.0 x 460mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529581114 Catalog Number :

Device Description : Tibial Insertion Bolt

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : No

Device Count : 1

Apex - 05391529581121 Catalog Number : F01-110240

Device Description : Apex Femoral Nail PF Left Ø 11.0 x 240mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529581138 Catalog Number : F01-110260

Device Description : Apex Femoral Nail PF Left Ø 11.0 x 260mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

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