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

Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (10)

Premarket Exempt

Clear

Leva™ Spacer System - 10840642100372 Catalog Number : 11-7307

Device Description : Fixed Implant 22mm x 10mm x 7mm

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Leva™ Spacer System - 10840642100389 Catalog Number : 11-7308

Device Description : Fixed Implant 22mm x 10mm x 8mm

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Leva™ Spacer System - 10840642100396 Catalog Number : 11-7309

Device Description : Fixed Implant 22mm x 10mm x 9mm

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Leva™ Spacer System - 10840642100402 Catalog Number : 11-7310

Device Description : Fixed Implant 22mm x 10mm x 10mm

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Leva™ Spacer System - 10840642100419 Catalog Number : 11-7311

Device Description : Fixed Implant 22mm x 10mm x 11mm

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Leva™ Spacer System - 10840642100426 Catalog Number : 11-7312

Device Description : Fixed 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 - 10840642100433 Catalog Number : 11-7313

Device Description : Fixed 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 - 10840642100440 Catalog Number : 11-7314

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

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Leva™ Spacer System - 10840642100457 Catalog Number : 11-7210

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

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Leva™ Spacer System - 10840642100464 Catalog Number : 11-7211

Device Description : Expandable Implant 22mm x 10mm x 11mm

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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