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

Appliance, Fixation, Spinal Intervertebral Body (KWQ) (2) Filler, Bone Void, Calcium Compound (MQV) (1) Orthopedic Stereotaxic Instrument (OLO) (1)

Premarket Exempt

Clear

Defender™ Anterior Cervical Plate System - 10840642168037 Catalog Number : 15-5934

Device Description : Variable Self-Tapping Screw, ø4.35 mm X 14 mm

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Defender™ Anterior Cervical Plate System - 10840642168051 Catalog Number : 15-5936

Device Description : Variable Self-Tapping Screw, ø4.35 mm X 16 mm

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Salvo® Spine System - 10840642168587 Catalog Number :

Device Description : 5.5/6.0 Screwdriver, Bone Screw, T25, NAV-M

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Tornado™ - 10840642168709 Catalog Number :

Device Description : Bioactive Bone Matrix, 5 cc Moldable Strip

Device Class : 2

Duns Number: 067789763

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

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