Surgalign Spine Technologies, Inc.

Address:520 Lake Cook Road,Deerfield,IL,60015,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 Manual Surgical Instrument (LXH) (6) Orthopedic Stereotaxic Instrument (OLO) (4)

Premarket Exempt

No Yes

Clear

HOLO Portal - 00850028694039 Catalog Number :

Device Description : Iliac Pin 100mm

Device Class : 1

Duns Number: 014520584

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

HOLO Portal - 00850028694046 Catalog Number :

Device Description : Iliac Pin 150mm

Device Class : 1

Duns Number: 014520584

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

HOLO Portal - 00850028694053 Catalog Number :

Device Description : Iliac Pin 200mm

Device Class : 1

Duns Number: 014520584

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

HOLO Portal - 00850028694060 Catalog Number :

Device Description : Iliac Pin 250mm

Device Class : 1

Duns Number: 014520584

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

HOLO Portal - 00850028694077 Catalog Number :

Device Description : Iliac Pin Cap

Device Class : 1

Duns Number: 014520584

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

HOLO Portal - 00850028694084 Catalog Number :

Device Description : HOLO Patient Array

Device Class : 2

Duns Number: 014520584

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

HOLO Portal - 00850028694091 Catalog Number :

Device Description : HOLO Instrument Calibration Tool, Sterile

Device Class : 2

Duns Number: 014520584

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

HOLO Portal - 00850028694107 Catalog Number :

Device Description : HOLO Instrument Array 1

Device Class : 2

Duns Number: 014520584

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

HOLO Portal - 00850028694114 Catalog Number :

Device Description : Streamline MIS Driver, Nav

Device Class : 2

Duns Number: 014520584

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

HOLO Portal - 00850028694121 Catalog Number :

Device Description : HOLO Hex Driver, Sterile

Device Class : 1

Duns Number: 014520584

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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