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 - 00810832030003 Catalog Number : 402105

Device Description : KTIS Calibration Bracket

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00810832030010 Catalog Number : 403007-14

Device Description : HIPALIGN INST. SET: DAA LL – US ONLY

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00810832030027 Catalog Number : 403007-15

Device Description : HIPALIGN INST. SET: DAA LL- Straight Impactor -03 Tray

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00810832030034 Catalog Number : 403007-16

Device Description : HIPALIGN INST. SET: DAA LL- Offset Impactor -03 Tray

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00810832030041 Catalog Number : 403007-17

Device Description : HIPALIGN INST. SET: DA/Supine Cup Placement

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

KneeAlign 2 - 00810832030058 Catalog Number : 402104

Device Description : BASE, TRAY, 10x10, KTIS

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00810832030065 Catalog Number : 403317-090

Device Description : Threaded Fixation Pin, 4.0 mm x 90mm, 3.2mm Proximal End

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00810832030072 Catalog Number : 403001

Device Description : OrthAlign Plus Unit - Gap Balancing

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00810832030096 Catalog Number : 403346

Device Description : Impactor System Adapter, Lima

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

OrthAlign Plus - 00810832030102 Catalog Number : 403415

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

Device Class : 2

Duns Number: 023266163

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

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