MAKO SURGICAL CORP.

Address:3365 ENTERPRISE AVE,Weston,FL,33331,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

Orthopedic stereotaxic instrument (OLO) (6) TRAY, SURGICAL, INSTRUMENT (FSM) (4)

Premarket Exempt

No Yes

Clear

NA - 07613327395280 Catalog Number : 219999

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Mako - 07613327395341 Catalog Number : 213951

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

STRYKER - 07613327409048 Catalog Number : 151251

Device Description : MAKO POWER TRAY BASE

Device Class : 1

Duns Number: 175239677

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

STRYKER - 07613327409055 Catalog Number : 214015

Device Description : ATTACHMENT WRENCH

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : OLO

Prescription Use : No

Device Count : 1

STRYKER - 07613327409086 Catalog Number : 151201

Device Description : MAKO KNEE TRAY BASE

Device Class : 1

Duns Number: 175239677

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

STRYKER - 07613327409116 Catalog Number : 151202

Device Description : MAKO KNEE TRAY UPPER TRAY

Device Class : 1

Duns Number: 175239677

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

NA - 07613327412369 Catalog Number : 213524

Device Description : BONE PINS (3.2MM X 110MM)

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

NA - 07613327412376 Catalog Number : 213527

Device Description : BONE PINS (3.2MM X 140MM)

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

NA - 07613327468298 Catalog Number : 700000380980

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

NA - 07613327468304 Catalog Number : 700000341417

Device Description : Mako THA Array Kit Upper Tray

Device Class : 1

Duns Number: 175239677

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

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