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

RETRACTOR (GAD) (6) Orthopedic stereotaxic instrument (OLO) (4)

Premarket Exempt

Yes No

Clear

NA - 00848486031909 Catalog Number : 210191

Device Description : BENT HOHMANN RETRACTOR

Device Class : 1

Duns Number: 175239677

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

NA - 00848486031916 Catalog Number : 210192

Device Description : SMILEY RETRACTOR

Device Class : 1

Duns Number: 175239677

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

NA - 00848486031923 Catalog Number : 210193

Device Description : RAKE RETRACTOR

Device Class : 1

Duns Number: 175239677

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

NA - 00848486031930 Catalog Number : 210194

Device Description : PCL RETRACTOR

Device Class : 1

Duns Number: 175239677

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

NA - 00848486031947 Catalog Number : 210195

Device Description : PATELLA RETRACTOR

Device Class : 1

Duns Number: 175239677

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

NA - 00848486031954 Catalog Number : 210196

Device Description : PATELLA PROTECTOR

Device Class : 1

Duns Number: 175239677

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

NA - 00848486031961 Catalog Number : 164001-18

Device Description : SPACER BLOCK 16/18mm

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

NA - 00848486031978 Catalog Number : 164001-20

Device Description : SPACER BLOCK 20/22mm

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Mako - 00848486031992 Catalog Number : 116171

Device Description : Blade - Narrow

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

NA - 00848486032111 Catalog Number : 212186

Device Description : Sagittal Saw Attachment

Device Class : 2

Duns Number: 175239677

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

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