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 Stereotaxic Instrument (OLO) (7) Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (2) Orthopedic Manual Surgical Instrument (LXH) (1)

Premarket Exempt

Yes No

Clear

HOLO Portal - 00850028694138 Catalog Number :

Device Description : Iliac Pin Removal Tool

Device Class : 1

Duns Number: 014520584

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

HOLO Portal - 00850028694145 Catalog Number :

Device Description : HOLO DU Screen Calibration Tool, Sterile

Device Class : 2

Duns Number: 014520584

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

HOLO Portal - 00850028694152 Catalog Number :

Device Description : ICT PAK Alignment Insert

Device Class : 2

Duns Number: 014520584

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

HOLO Portal - 00850028694169 Catalog Number :

Device Description : ICT Inserter Alignment Insert

Device Class : 2

Duns Number: 014520584

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

HOLO Portal - 00850028694367 Catalog Number :

Device Description : PAK Needle Calibration Instrument

Device Class : 2

Duns Number: 014520584

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

HOLO Portal - 00850028694374 Catalog Number :

Device Description : Screw Inserter Calibration Instrument

Device Class : 2

Duns Number: 014520584

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

HOLO Portal - 00850028694381 Catalog Number :

Device Description : Holo AR Mirror, Sterile

Device Class : 2

Duns Number: 014520584

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

HOLO Portal - 00850028694404 Catalog Number :

Device Description : HOLO ARAI System

Device Class : 2

Duns Number: 014520584

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Fortilink - 04260636678936 Catalog Number :

Device Description : Fortilink-C TiPlus Inserter, Housing

Device Class : 2

Duns Number: 014520584

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Fortilink - 04260636678967 Catalog Number :

Device Description : TiPlus-TC Inserter, Straight

Device Class : 2

Duns Number: 014520584

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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