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

Orthopedic Manual Surgical Instrument (LXH) (2)

Premarket Exempt

No Yes

Clear

Apex - 05391529588694 Catalog Number : INS-1155

Device Description : K-Wire Trocar(Length 227mm)

Device Class : 1

Duns Number: 985596830

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Apex - 05391529588700 Catalog Number : INS-1156

Device Description : Flexible IM Reamer Shaft 650mm

Device Class : 1

Duns Number: 985596830

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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