SPINE INNOVATION, LLC

Address:2010 Jimmy Durante Blvd,Del Mar,CA,92014,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

Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (4)

Premarket Exempt

Clear

Spine Innovation Interbody System - 00817722021004 Catalog Number :

Device Description : Expansion Wedge, 12mm W x 8mm H x 26mm L

Device Class : 2

Duns Number: 080376573

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Spine Innovation Interbody System - 00817722021011 Catalog Number :

Device Description : Expansion Wedge, 12mm W x 8mm H x 30mm L

Device Class : 2

Duns Number: 080376573

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Spine Innovation Interbody System - 00817722021028 Catalog Number :

Device Description : Palm Handle

Device Class : 2

Duns Number: 080376573

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Spine Innovation Interbody System - 00817722021035 Catalog Number :

Device Description : Shim Handle

Device Class : 2

Duns Number: 080376573

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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