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) (7) Orthopedic Manual Surgical Instrument (LXH) (2) Screwdriver (HXX) (1)

Premarket Exempt

No Yes

Clear

Apex - 05391529588465 Catalog Number : E04-000

Device Description : Apex Endcap Tibial/Retrograde 0mm Length

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529588472 Catalog Number : E04-005

Device Description : Apex Endcap Tibial/Retrograde 5mm Length

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529588489 Catalog Number : E04-010

Device Description : Apex Endcap Tibial/Retrograde 10mm Length

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529588496 Catalog Number : E04-015

Device Description : Apex Endcap Tibial/Retrograde 15mm Length

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529588502 Catalog Number : E04-020

Device Description : Apex Endcap Tibial/Retrograde 20mm Length

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529588519 Catalog Number : LE04-000

Device Description : Apex Locking Endcap Tibial/Retrograde 0mm Length

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529588656 Catalog Number : INS-1151

Device Description : Flexible Hex Driver Ball Tip (5mm/8mm)

Device Class : 1

Duns Number: 985596830

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

Apex - 05391529588663 Catalog Number : INS-1152

Device Description : Orthopedic instrument surgical connector

Device Class : 2

Duns Number: 985596830

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Apex - 05391529588670 Catalog Number : INS-1153

Device Description : Yellow Trocar(Length 227mm)

Device Class : 1

Duns Number: 985596830

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Apex - 05391529588687 Catalog Number : INS-1154

Device Description : Orange Purple Trocar(Length 227mm)

Device Class : 1

Duns Number: 985596830

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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