NVISION BIOMEDICAL TECHNOLOGIES, INC.

Address:4590 Lockhill Selma,San Antonio,TX,78249,US

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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) (7)

Premarket Exempt

No Yes

Clear

Boundary - 90814008025476 Catalog Number :

Device Description : Buttress Plate Screw 25mm long, 6.0mm circumference, non-locking. The Boundary Buttress Plate Screw 25mm long, 6.0mm circumference, non-locking. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

Device Class : 2

Duns Number: 047486041

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Boundary - 90814008025483 Catalog Number :

Device Description : Buttress Plate Screw 30mm long, 6.0mm circumference, non-locking. The Boundary Buttress Plate Screw 30mm long, 6.0mm circumference, non-locking. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

Device Class : 2

Duns Number: 047486041

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Boundary - 90814008025490 Catalog Number :

Device Description : Buttress Plate Screw 35mm long, 6.0mm circumference, non-locking. The Boundary Buttress Plate Screw 35mm long, 6.0mm circumference, non-locking. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

Device Class : 2

Duns Number: 047486041

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Boundary - 90814008025506 Catalog Number :

Device Description : Buttress Plate Screw 20mm long, 6.0mm circumference, locking. The Boundary Ante Buttress Plate Screw 20mm long, 6.0mm circumference, locking. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

Device Class : 2

Duns Number: 047486041

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Boundary - 90814008025513 Catalog Number :

Device Description : Buttress Plate Screw 25mm long, 6.0mm circumference, locking. The Boundary Ante Buttress Plate Screw 25mm long, 6.0mm circumference, locking. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

Device Class : 2

Duns Number: 047486041

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Boundary - 90814008025520 Catalog Number :

Device Description : Buttress Plate Screw 30mm long, 6.0mm circumference, locking. The Boundary Ante Buttress Plate Screw 30mm long, 6.0mm circumference, locking. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

Device Class : 2

Duns Number: 047486041

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Boundary - 90814008025537 Catalog Number :

Device Description : Buttress Plate Screw 35mm long, 6.0mm circumference, locking. The Boundary Ante Buttress Plate Screw 35mm long, 6.0mm circumference, locking. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

Device Class : 2

Duns Number: 047486041

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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