Spine Wave, Inc.

Address:THREE ENTERPRISE DR.,SHELTON,CT,06484,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

Spinal Vertebral Body Replacement Device (MQP) (7) Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (3)

Premarket Exempt

Clear

Leva™ Spacer System - 10840642100471 Catalog Number : 11-7212

Device Description : Expandable Implant 22mm x 10mm x 12mm

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Leva™ Spacer System - 10840642100488 Catalog Number : 11-7213

Device Description : Expandable Implant 22mm x 10mm x 13mm

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Leva™ Spacer System - 10840642100495 Catalog Number : 11-7214

Device Description : Expandable Implant 22mm x 10mm x 14mm

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

StaXx® XD System - 10840642100518 Catalog Number : 11-1175

Device Description : Cartridge Convex Expandable Implant Wide 25x11x7mm

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

StaXx® XD System - 10840642100525 Catalog Number : 11-1179

Device Description : Cartridge Convex Expandable Implant Wide 29x11x7mm

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

StaXx® XD System - 10840642100563 Catalog Number : 11-1192

Device Description : Cartridge Convex Expandable Implant Wide 22x11x21mm

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

StaXx® XD System - 10840642100570 Catalog Number : 11-1195

Device Description : Cartridge Convex Expandable Implant Wide 25x11x21mm

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

StaXx® XD System - 10840642100594 Catalog Number : 11-1323

Device Description : Cartridge Convex Expandable Implant 24x9x7mm

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

StaXx® XD System - 10840642100600 Catalog Number : 11-1326

Device Description : Cartridge Convex Expandable Implant 26x9x7mm

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

StaXx® XD System - 10840642100655 Catalog Number : 11-1522

Device Description : Cartridge Convex Expandable Implant 22x9x7mm

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

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