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) (8) Orthopedic Manual Surgical Instrument (LXH) (1) Orthopedic Tray (OJH) (1)

Premarket Exempt

No Yes

Clear

PerX360 System, Implant Caddy - 81195401243424 Catalog Number : 6208-00

Device Class : 1

Duns Number: 017663522

Premarket Exempt : Yes

Product Code : OJH

Prescription Use : Yes

Device Count : 1

Access Needle - 81195401244100 Catalog Number : 6949

Device Description : PERPOS PLS System, Access Needle

Device Class : 1

Duns Number: 017663522

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Opticage Expandable Interbody Implant - 81195401245886 Catalog Number : 9080-12

Device Description : 16mm 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 - 81195401246562 Catalog Number : 9080-13

Device Description : 16mm 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 - 81195401247248 Catalog Number : 9080-14

Device Description : 16mm 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 - 81195401248924 Catalog Number : 9080-15

Device Description : 16mm 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

Opticage Expandable Interbody Implant - 81195401249600 Catalog Number : 9080-16

Device Description : 18mm 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 - 81195401250286 Catalog Number : 9080-17

Device Description : 18mm 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 - 81195401251962 Catalog Number : 9080-18

Device Description : 18mm 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 - 81195401252648 Catalog Number : 9080-19

Device Description : 18mm 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

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