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 - 05391529580940 Catalog Number : F01-850400

Device Description : Apex Femoral Nail PF Left Ø 8.5 x 400mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529580957 Catalog Number : F01-850420

Device Description : Apex Femoral Nail PF Left Ø 8.5 x 420mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529580964 Catalog Number : F01-850440

Device Description : Apex Femoral Nail PF Left Ø 8.5 x 440mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529580971 Catalog Number : F01-850460

Device Description : Apex Femoral Nail PF Left Ø 8.5 x 460mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529580988 Catalog Number : F01-850480

Device Description : Apex Femoral Nail PF Left Ø 8.5 x 480mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529580995 Catalog Number : F01-100240

Device Description : Apex Femoral Nail PF Left Ø 10.0 x 240mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529581008 Catalog Number : F01-100260

Device Description : Apex Femoral Nail PF Left Ø 10.0 x 260mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529581015 Catalog Number : F01-100280

Device Description : Apex Femoral Nail PF Left Ø 10.0 x 280mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529581022 Catalog Number : F01-100300

Device Description : Apex Femoral Nail PF Left Ø 10.0 x 300mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529581039 Catalog Number : F01-100320

Device Description : Apex Femoral Nail PF Left Ø 10.0 x 320mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

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