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 - 00858704006947 Catalog Number : 403158

Device Description : Probe Mount, 60mm

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00858704006954 Catalog Number : 403162

Device Description : Pin Driver, Tri-flat, Hudson Connector

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00858704006961 Catalog Number : 403169

Device Description : Adapter,Implant,Off 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 - 00858704006978 Catalog Number : 403171

Device Description : Adapter,Implant,Off 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 - 00858704006985 Catalog Number : 403172

Device Description : Adapter,Implant,Off 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 - 00858704006992 Catalog Number : 403173

Device Description : Adapter,Implant,Off Impactr,M10X1.5,MAXX

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 10810832030499 Catalog Number : 403478

Device Description : Threaded Femur Tack, 10-pack, N/S

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 20810832030922 Catalog Number :

Device Description : Individual, Sterile Standard 4mm Pin Pack

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 20810832030939 Catalog Number :

Device Description : Individual, Sterile Short 4mm Pin Pack

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 20810832030946 Catalog Number :

Device Description : Individual, Long 4mm Pin Pack

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

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