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 - 00810832030126 Catalog Number : 403421

Device Description : Impactor, Straight, Unibody, 7/16-20, DPY

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00810832030133 Catalog Number : 403422

Device Description : Impactor, Straight, Unibody, 3/8-24, S/B

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00810832030140 Catalog Number : 403423

Device Description : Impactor, Straight, Unibody, 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 - 00810832030157 Catalog Number : 403424

Device Description : Impactor, Straight, Unibody, 5/16-24, ZIM

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00810832030164 Catalog Number : 403425

Device Description : Impactor, Straight, Unibody, 3/8-32, WT

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00810832030171 Catalog Number : 403426

Device Description : Impactor, Straight, Unibody, 1/4-28, DJO

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00810832030188 Catalog Number : 403427

Device Description : Impactor, Straight, Unibody, M10 x 1.5, MAX

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

KneeAlign 2 - 00810832030195 Catalog Number : 402096

Device Description : Femoral Tensor Instrument

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

KneeAlign 2 - 00810832030201 Catalog Number : 402097

Device Description : Tibial Tensor Instrument

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

KneeAlign 2 - 00810832030218 Catalog Number : 402098

Device Description : GUIDE,ALIGNMENT,KTIS

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

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