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) (9) Spinal Vertebral Body Replacement Device (MQP) (1)

Premarket Exempt

Clear

Leva™ Spacer System - 10840642100013 Catalog Number : 11-7010

Device Description : Expandable Implant 25mm 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 - 10840642100020 Catalog Number : 11-7011

Device Description : Expandable Implant 25mm 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 - 10840642100037 Catalog Number : 11-7012

Device Description : Expandable Implant 25mm 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 - 10840642100044 Catalog Number : 11-7013

Device Description : Expandable Implant 25mm 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 - 10840642100051 Catalog Number : 11-7014

Device Description : Expandable Implant 25mm 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 - 10840642100068 Catalog Number : 11-7015

Device Description : Expandable Implant 25mm x 10mm x 15mm

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Leva™ Spacer System - 10840642100075 Catalog Number : 11-7107

Device Description : Fixed Implant 25mm 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 - 10840642100082 Catalog Number : 11-7108

Device Description : Fixed Implant 25mm 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 - 10840642100099 Catalog Number : 11-7109

Device Description : Fixed Implant 25mm x 10mm x 9mm

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

StaXx® XD System - 10840642100105 Catalog Number : 11-1666

Device Description : Cartridge Lordotic Expandable Implant Ti 22x9x8mm 15deg

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

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