ORTHALIGN, INC.

Address:120 Columbia,Aliso Viejo,CA,92656,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) (10)

Premarket Exempt

No Yes

Clear

OrthAlign Plus - 00858704006848 Catalog Number : 401638

Device Description : Pin, Headless, Smooth, 65 mm

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00858704006855 Catalog Number : 403027

Device Description : Adapter,Implant,Str Impactr,7/16-20,DPY

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00858704006862 Catalog Number : 403029

Device Description : Adapter,Implant,Str Impactr,3/8-16,S&N

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00858704006879 Catalog Number : 403031

Device Description : Adapter,Implant,Str Impactr,3/8-32,WT

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00858704006886 Catalog Number : 403033

Device Description : Adapter,Implant,Str Impactr,M10x1.5,MAX

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00858704006893 Catalog Number : 403032

Device Description : Adapter,Implant,Str Impactr,1/4-28,DJO

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00858704006909 Catalog Number : 403153

Device Description : Threaded Fixation Pin, 5MM X 170MM

Device Class :

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00858704006916 Catalog Number : 403154

Device Description : Drill Guide, 140mm Cannula

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00858704006923 Catalog Number : 403155

Device Description : 5mm Trocar

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00858704006930 Catalog Number : 403157

Device Description : Registration Probe

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

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