DEPUY INTERNATIONAL LTD

DEPUY INTERNATIONAL LTD

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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

TEMPLATE (HWT) (6) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (3) SCREWDRIVER (HXX) (1)

Premarket Exempt

No Yes

Clear

NA - 10603295026853 Catalog Number : 129901029

Device Description : CAS SYSTEM HANDLE

Device Class : 1

Duns Number: 896498813

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

PATHWAY - 10603295026860 Catalog Number : 129901030

Device Description : PATHWAY DISASSEMBLY DRIVER

Device Class : 1

Duns Number: 896498813

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : No

Device Count : 1

NA - 10603295026914 Catalog Number : 129901054

Device Description : CAS Ligament Tensor Handle

Device Class : 1

Duns Number: 896498813

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

NA - 10603295026921 Catalog Number : 129901055

Device Description : CAS Tensor Spacer 5mm

Device Class : 1

Duns Number: 896498813

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

NA - 10603295026938 Catalog Number : 129901056

Device Description : CAS Tensor Spacer 10mm

Device Class : 1

Duns Number: 896498813

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

NA - 10603295026952 Catalog Number : 129901058

Device Description : CAS Bone Fixator 3.5MM

Device Class : 1

Duns Number: 896498813

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

PATHWAY - 10603295026969 Catalog Number : 129901061

Device Description : PATHWAY TIBIAL SCREW 21mm

Device Class : 1

Duns Number: 896498813

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NA - 10603295027072 Catalog Number : 129901080

Device Description : CAS LIGAMENT TENSOR SIZE 2-XF

Device Class : 1

Duns Number: 896498813

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

NA - 10603295027089 Catalog Number : 129901081

Device Description : CAS LIGAMENT TENSOR SIZE 4-XF

Device Class : 1

Duns Number: 896498813

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

NA - 10603295027096 Catalog Number : 129901085

Device Description : CAS Ligament Tensor Handle Kit

Device Class : 1

Duns Number: 896498813

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

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