MAKO SURGICAL CORP.

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 PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER (NPJ) (8) PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER (HSX) (8) PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER (HRY) (8) PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER (KRR) (8) Orthopedic stereotaxic instrument (OLO) (2)

Premarket Exempt

No Yes

Clear

NA - 00848486000004 Catalog Number : 110740

Device Description : SOCKET ARRAY

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

NA - 00848486000042 Catalog Number : 111770

Device Description : KNEE END EFFECTOR

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

RESTORIS - 00848486000349 Catalog Number : 180320-2

Device Description : MCK Patella Component

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : HRY, KRR, HSX, NPJ

Prescription Use : Yes

Device Count : 1

RESTORIS - 00848486000356 Catalog Number : 180320-1

Device Description : MCK Patella Component

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : NPJ, HSX, HRY, KRR

Prescription Use : Yes

Device Count : 1

RESTORIS - 00848486000363 Catalog Number : 180320-3

Device Description : MCK Patella Component

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : HRY, HSX, KRR, NPJ

Prescription Use : Yes

Device Count : 1

RESTORIS - 00848486000370 Catalog Number : 180320-4

Device Description : MCK Patella Component

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : NPJ, HSX, HRY, KRR

Prescription Use : Yes

Device Count : 1

RESTORIS - 00848486000387 Catalog Number : 180320-5

Device Description : MCK Patella Component

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : NPJ, HSX, HRY, KRR

Prescription Use : Yes

Device Count : 1

RESTORIS - 00848486000394 Catalog Number : 180320-6

Device Description : MCK Patella Component

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : HSX, KRR, NPJ, HRY

Prescription Use : Yes

Device Count : 1

RESTORIS - 00848486000400 Catalog Number : 180402

Device Description : MCK Patellofemoral Component

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : HRY, KRR, NPJ, HSX

Prescription Use : Yes

Device Count : 1

RESTORIS - 00848486000417 Catalog Number : 180403

Device Description : MCK Patellofemoral Component

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : HSX, NPJ, KRR, HRY

Prescription Use : Yes

Device Count : 1

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