DEPUY MITEK, LLC

Address:325 Paramount Dr,RAYNHAM,MA,02767,US

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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

FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE (MAI) (2) PIN, FIXATION, SMOOTH (HTY) (2) Guide, surgical, instrument (FZX) (1) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (1)

Premarket Exempt

No Yes

Clear

NA - 20886705012913 Catalog Number : 254417

Device Description : Nitinol Guidewire 1.1mm x 22.9cm (9 Inches)

Device Class :

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : Yes

Device Count : 6

FMS - 20886705016065 Catalog Number : 281380

Device Description : FMS Waste Collection Bag

Device Class :

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 25

RIGIDFIX - 20886705020000 Catalog Number : 213013

Device Description : RIGIDFIX CURVE ST ACL PLA Cross Pin System (2) each ST Cross Pins, 3.3mm x 42mm RIGIDFIX CURVE ST ACL PLA Cross Pin System (2) each ST Cross Pins, 3.3mm x 42mm Poly Lactic Acid (PLA), (2) each Sleeve Assemblies, (1) each Interlocking Trocar, (1) Pusher Rod, and (1) Bone Gauge Pin

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : MAI, HTY

Prescription Use : Yes

Device Count : 1

RIGIDFIX - 20886705020017 Catalog Number : 213015

Device Description : RIGIDFIX CURVE ST ACL PEEK Cross Pin System (2) each ST Cross Pins, 3.3mm x 42mm RIGIDFIX CURVE ST ACL PEEK Cross Pin System (2) each ST Cross Pins, 3.3mm x 42mm PEEK, (2) each Sleeve Assemblies, (1) each Interlocking Trocar, (1) Pusher Rod, and (1) Bone Gauge Pin

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : MAI, HTY

Prescription Use : Yes

Device Count : 1

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