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) (10)

Premarket Exempt

No Yes

Clear

8 Degree Lordotic, Opticage Expandable Interbody Implant - 00011954013448 Catalog Number : 9101-21

Device Description : 22mm Width x 45mm Length by 11mm-16mm Footprint Length

Device Class : 2

Duns Number: 017663522

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Opticage Expandable Interbody Implant - 00811954011420 Catalog Number : 9180-00

Device Description : 9mm Width by 21mm Expanded Height, 9mm, by 9mm - 14mm Height Range

Device Class : 2

Duns Number: 017663522

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Opticage Expandable Interbody Implant - 00811954011437 Catalog Number : 9180-01

Device Description : 9mm Width by 26mm Expanded Height, 9mm, by 9mm - 14mm Height Range

Device Class : 2

Duns Number: 017663522

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Opticage Expandable Interbody Implant - 00811954011444 Catalog Number : 9180-02

Device Description : 9mm Width by 30mm Expanded Height, 9mm, by 9mm - 14mm Height Range

Device Class : 2

Duns Number: 017663522

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Opticage Expandable Interbody Implant - 00811954011451 Catalog Number : 9180-03

Device Description : 10mm Width by 21mm Expanded Height, 9mm, by 9mm - 14mm Height Range

Device Class : 2

Duns Number: 017663522

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Opticage Expandable Interbody Implant - 00811954011468 Catalog Number : 9180-04

Device Description : 10mm Width by 26mm Expanded Height, 9mm, by 9mm - 14mm Height Range

Device Class : 2

Duns Number: 017663522

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Opticage Expandable Interbody Implant - 00811954011475 Catalog Number : 9180-05

Device Description : 10mm Width by 30mm Expanded Height, 9mm, by 9mm - 14mm Height Range

Device Class : 2

Duns Number: 017663522

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Opticage Expandable Interbody Implant - 00811954011482 Catalog Number : 9180-06

Device Description : 11mm Width by 21mm Expanded Height, 9mm, by 9mm - 14mm Height Range

Device Class : 2

Duns Number: 017663522

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Opticage Expandable Interbody Implant - 00811954011499 Catalog Number : 9180-07

Device Description : 11mm Width by 26mm Expanded Height, 9mm, by 9mm - 14mm Height Range

Device Class : 2

Duns Number: 017663522

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Opticage Expandable Interbody Implant - 00811954011505 Catalog Number : 9180-08

Device Description : 11mm Width by 30mm Expanded Height, 9mm, by 9mm - 14mm Height Range

Device Class : 2

Duns Number: 017663522

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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