Stryker Corporation

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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) Catheter, Percutaneous, Neurovasculature (QJP) (2) CATHETER, THROMBUS RETRIEVER (NRY) (2) INSTRUMENT, MANUAL, SURGICAL, GENERAL USE (MDM) (1) Injector, vertebroplasty (does not contain cement) (OAR) (1) Orthopedic manual surgical instrument (LXH) (1) Syringe, piston (FMF) (1) CEMENT, BONE, VERTEBROPLASTY (NDN) (1) DISPENSER, CEMENT (KIH) (1)

Premarket Exempt

No Yes

Clear

AXS VECTA 46 - 07613327519372 Catalog Number : INC-11814-153

Device Description : Intermediate Catheter

Device Class : 2

Duns Number: 042405446

Premarket Exempt : No

Product Code : NRY, QJP

Prescription Use : Yes

Device Count : 1

AXS VECTA 46 - 07613327519389 Catalog Number : INC-11814-160

Device Description : Intermediate Catheter

Device Class : 2

Duns Number: 042405446

Premarket Exempt : No

Product Code : QJP, NRY

Prescription Use : Yes

Device Count : 1

LITe Bio - 07613327524000 Catalog Number : IS4474REL

Device Description : Specialty LITe Bio Loading Funnel

Device Class : 1

Duns Number: 149183167

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Monterey AL - 07613327524468 Catalog Number : 48019125

Device Description : Bent Awl

Device Class : 1

Duns Number: 149183167

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Tritanium PL - 07613327538267 Catalog Number : IS4587TPL02

Device Description : Specialty Tritanium PL 11mm Pistol Grip Inserter

Device Class : 1

Duns Number: 149183167

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Tritanium PL - 07613327538281 Catalog Number : IS4587TPL01

Device Description : Specialty Tritanium PL 8-9mm Pistol Grip Inserter

Device Class : 1

Duns Number: 149183167

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Stroke Fast Pack - 07613327548365 Catalog Number : 91317

Device Class :

Duns Number: 042405446

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

Vitagel - 30808232000833 Catalog Number : 2090-0036

Device Description : Spray Set

Device Class :

Duns Number: 149183167

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 5

Cortoss - 30808232000949 Catalog Number : 2110-0031

Device Description : Mix Tips, Luer

Device Class :

Duns Number: 149183167

Premarket Exempt : No

Product Code : NDN

Prescription Use : Yes

Device Count : 3

Aliquot - 30808232001137 Catalog Number : 2110-0507

Device Description : Flexible Extensions

Device Class :

Duns Number: 149183167

Premarket Exempt : Yes

Product Code : OAR, KIH

Prescription Use : Yes

Device Count : 3

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