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

PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER (HSX) (4) Orthopedic stereotaxic instrument (OLO) (3) TRAY, SURGICAL, INSTRUMENT (FSM) (3) PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER (NPJ) (2) PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER (HRY) (2) PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER (KRR) (2)

Premarket Exempt

Yes No

Clear

NA - 00848486032128 Catalog Number : 212480

Device Description : Right Angle Saw Attachment

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

NA - 00848486032135 Catalog Number : 206693

Device Description : MICS Adapter Cap

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

RESTORIS, RIO - 00848486032142 Catalog Number : 212760

Device Description : OFFSET CUP REAMER HANDLE

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

RESTORIS - 07613327253436 Catalog Number : 150093

Device Description : MCK PF METAL INS TRAY LID

Device Class : 1

Duns Number: 175239677

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

MAKOPLASTY - 07613327253535 Catalog Number : 150271

Device Description : Acetabular Reamer Basket Case Assembly

Device Class : 1

Duns Number: 175239677

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

RESTORIS - 07613327253573 Catalog Number : 160111

Device Description : MCK PF TEMPLATE (1 RIGHT)

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : HRY, HSX, KRR, NPJ

Prescription Use : Yes

Device Count : 1

RESTORIS - 07613327253597 Catalog Number : 160101

Device Description : MCK PF TEMPLATE (1 LEFT)

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : KRR, HSX, HRY, NPJ

Prescription Use : Yes

Device Count : 1

MAKO - 07613327253603 Catalog Number : 150243

Device Description : INSTRUMENT TRAY LID

Device Class : 1

Duns Number: 175239677

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Mako - 07613327385687 Catalog Number : 180731-1-E

Device Description : MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 1 - 8 MM

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : HSX

Prescription Use : Yes

Device Count : 1

Mako - 07613327385694 Catalog Number : 180731-3-E

Device Description : MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 1 - 10 MM

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : HSX

Prescription Use : Yes

Device Count : 1

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