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) (10) PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER (HSX) (10) PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER (HRY) (10) PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER (KRR) (10)

Premarket Exempt

No Yes

Clear

RESTORIS - 00848486000721 Catalog Number : 180606

Device Description : MCK Onlay Tibia Baseplate

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : HSX, HRY, KRR, NPJ

Prescription Use : Yes

Device Count : 1

RESTORIS - 00848486000738 Catalog Number : 180607

Device Description : MCK Onlay Tibia Baseplate

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : NPJ, KRR, HSX, HRY

Prescription Use : Yes

Device Count : 1

RESTORIS - 00848486000745 Catalog Number : 180608

Device Description : MCK Onlay Tibia Baseplate

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : NPJ, HSX, HRY, KRR

Prescription Use : Yes

Device Count : 1

RESTORIS - 00848486000752 Catalog Number : 180612

Device Description : MCK Onlay Tibia Baseplate

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : NPJ, KRR, HRY, HSX

Prescription Use : Yes

Device Count : 1

RESTORIS - 00848486000769 Catalog Number : 180613

Device Description : MCK Onlay Tibia Baseplate

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : KRR, NPJ, HSX, HRY

Prescription Use : Yes

Device Count : 1

RESTORIS - 00848486000776 Catalog Number : 180614

Device Description : MCK Onlay Tibia Baseplate

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : HSX, NPJ, KRR, HRY

Prescription Use : Yes

Device Count : 1

RESTORIS - 00848486000783 Catalog Number : 180615

Device Description : MCK Onlay Tibia Baseplate

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : HRY, NPJ, KRR, HSX

Prescription Use : Yes

Device Count : 1

RESTORIS - 00848486000790 Catalog Number : 180616

Device Description : MCK Onlay Tibia Baseplate

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : KRR, NPJ, HRY, HSX

Prescription Use : Yes

Device Count : 1

RESTORIS - 00848486000806 Catalog Number : 180617

Device Description : MCK Onlay Tibia Baseplate

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : NPJ, KRR, HRY, HSX

Prescription Use : Yes

Device Count : 1

RESTORIS - 00848486000813 Catalog Number : 180618

Device Description : MCK Onlay Tibia Baseplate

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : NPJ, HRY, KRR, HSX

Prescription Use : Yes

Device Count : 1

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