ORTHOXEL DESIGNATED ACTIVITY COMPANY

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

Screw, Fixation, Bone (HWC) (7) Rod, Fixation, Intramedullary And Accessories (HSB) (3)

Premarket Exempt

No Yes

Clear

Apex - 05391529580148 Catalog Number :

Device Description : Apex Tibial Screw, Sterile

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Apex - 05391529580155 Catalog Number :

Device Description : Apex Tibial Screw, Sterile

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Apex - 05391529580162 Catalog Number :

Device Description : Apex Tibial Screw, Sterile

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Apex - 05391529580179 Catalog Number :

Device Description : Apex Tibial Screw, Sterile

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Apex - 05391529580186 Catalog Number :

Device Description : Apex Tibial Screw, Sterile

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Apex - 05391529580193 Catalog Number :

Device Description : Apex Tibia Screw, Sterile

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Apex - 05391529580582 Catalog Number :

Device Description : Apex Tibial Nail, Sterile

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529580599 Catalog Number :

Device Description : Apex Tibial Nail Ø11.5 x 360mm

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

NA - 05391529580766 Catalog Number : E01-000

Device Description : Apex Tibial Endcap

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Apex - 05391529580773 Catalog Number :

Device Description : Apex Tibial Endcap

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

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