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

KneeAlign 2 - 00810832030225 Catalog Number : 402103

Device Description : BRACKET NAV UNIT, KTIS

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

KneeAlign 2 - 00810832030232 Catalog Number : 402100-01

Device Description : Balancing Application Instrument Kit

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00810832030249 Catalog Number : 403007-18

Device Description : HIPALIGN INST. SET: DAA LL – Core Set

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

KneeAlign 2 - 00810832030256 Catalog Number : 401650

Device Description : Tibial Cutting Block, Right, Rapid Traverse

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

KneeAlign 2 - 00810832030263 Catalog Number : 401651

Device Description : Tibial Cutting Block, Left, Rapid Traverse

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00810832030270 Catalog Number : 403430-01

Device Description : Implant Adapter, Magnetic, 3/8-1/2

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00810832030287 Catalog Number : 403430-02

Device Description : Implant Adapter, Magnetic, 9/16-7/8

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00810832030294 Catalog Number : 403174

Device Description : Adapter,Implant,Off Impactr, M8x1.25, LIM

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00810832030300 Catalog Number : 403430-04

Device Description : Universal RS Adapter, Small- .325"-.500"

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00810832030317 Catalog Number : 403430-05

Device Description : Universal RS Adapter, Large- .485"-.750"

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

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