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

Opticage Expandable Interbody Implant - 00811954011512 Catalog Number : 9180-09

Device Description : 12mm 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 - 00811954011529 Catalog Number : 9180-10

Device Description : 12mm 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 - 00811954011536 Catalog Number : 9180-11

Device Description : 12mm 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 - 00811954011543 Catalog Number : 9180-12

Device Description : 16mm Width by 40mm 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 - 00811954011550 Catalog Number : 9180-13

Device Description : 16mm Width by 45mm 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 - 00811954011567 Catalog Number : 9180-14

Device Description : 16mm Width by 50mm 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 - 00811954011574 Catalog Number : 9180-15

Device Description : 16mm Width by 55mm 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 - 00811954011581 Catalog Number : 9180-16

Device Description : 18mm Width by 40mm 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 - 00811954011598 Catalog Number : 9180-17

Device Description : 18mm Width by 45mm 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 - 00811954011604 Catalog Number : 9180-18

Device Description : 18mm Width by 50mm 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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