INTERVENTIONAL SPINE, INC

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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

Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (4) Orthopedic Manual Surgical Instrument (LXH) (1)

Premarket Exempt

No Yes

Clear

Opticage Expandable Interbody Implant - 81195401253324 Catalog Number : 9080-20

Device Description : 22mm Width x 40mm Length by 9mm-14mm Expandable Height

Device Class : 2

Duns Number: 017663522

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Opticage Expandable Interbody Implant - 81195401254000 Catalog Number : 9080-21

Device Description : 21mm Width x 45mm Length by 9mm-14mm Expandable Height

Device Class : 2

Duns Number: 017663522

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Opticage Expandable Interbody Implant - 81195401255786 Catalog Number : 9080-22

Device Description : 22mm Width x 50mm Length by 9mm-14mm Expandable Height

Device Class : 2

Duns Number: 017663522

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Opticage Expandable Interbody Implant - 81195401256462 Catalog Number : 9080-23

Device Description : 22mm Width x 55mm Length by 9mm-14mm Expandable Height

Device Class : 2

Duns Number: 017663522

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

3.8 CS Curved Sheath Assembly - 81195407130032 Catalog Number : 6088-00

Device Class : 1

Duns Number: 017663522

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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