Boundary

GUDID 90814008025483

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.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system

• Primary Device ID: 90814008025483
• NIH Device Record Key: d629aad2-bfd1-4dea-8084-5f86fb9e956f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Boundary
• Version Model Number: ALB-60S-30
• Company DUNS: 047486041
• Company Name: NVISION BIOMEDICAL TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com

Device Dimensions

• Circumference: 6 Millimeter
• Circumference: 6 Millimeter
• Circumference: 6 Millimeter
• Circumference: 6 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
• Special Storage Condition, Specify: Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time

Device Identifiers

Device Issuing Agency	Device ID
GS1	90814008025483 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173091

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[90814008025483]

Moist Heat or Steam Sterilization

[90814008025483]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-20
• Device Publish Date: 2018-02-28

On-Brand Devices [Boundary]

• 00814008029808: Instrument, Lumbar Buttress Plate Ratchet Sport Grip AO Handle. The Boundary Anterior Lumbar Bu
• 00814008025589: Instrument, Lumbar Buttress Plate Screw Inserter. The Boundary Anterior Lumbar Buttress Plate i
• 00814008025572: Instrument, Lumbar Buttress Plate Inserter. The Boundary Anterior Lumbar Buttress Plate is inte
• 00814008025565: Instrument, Lumbar Buttress Plate Tap. The Boundary Anterior Lumbar Buttress Plate is intended
• 00814008025558: Instrument, Lumbar Buttress Plate Drill. The Boundary Anterior Lumbar Buttress Plate is intende
• 00814008025541: Instrument, Lumbar Buttress Plate Awl. The Boundary Anterior Lumbar Buttress Plate is intended
• 90814008025537: Buttress Plate Screw 35mm long, 6.0mm circumference, locking. The Boundary Anterior Lumbar Butt
• 90814008025520: Buttress Plate Screw 30mm long, 6.0mm circumference, locking. The Boundary Anterior Lumbar Butt
• 90814008025513: Buttress Plate Screw 25mm long, 6.0mm circumference, locking. The Boundary Anterior Lumbar Butt
• 90814008025506: Buttress Plate Screw 20mm long, 6.0mm circumference, locking. The Boundary Anterior Lumbar Butt
• 90814008025490: Buttress Plate Screw 35mm long, 6.0mm circumference, non-locking. The Boundary Anterior Lumbar
• 90814008025483: Buttress Plate Screw 30mm long, 6.0mm circumference, non-locking. The Boundary Anterior Lumbar
• 90814008025476: Buttress Plate Screw 25mm long, 6.0mm circumference, non-locking. The Boundary Anterior Lumbar
• 90814008025469: Buttress Plate Screw 20mm long, 6.0mm circumference, non-locking. The Boundary Anterior Lumbar
• 90814008025452: Buttress Plate Screw 35mm long, 5.5mm circumference, locking. The Boundary Anterior Lumbar Butt
• 90814008025445: Buttress Plate Screw 30mm long, 5.5mm circumference, locking. The Boundary Anterior Lumbar Butt
• 90814008025438: Buttress Plate Screw 25mm long, 5.5mm circumference, locking. The Boundary Anterior Lumbar Butt
• 90814008025421: Buttress Plate Screw 20mm long, 5.5mm circumference, locking. The Boundary Anterior Lumbar Butt
• 90814008025414: Buttress Plate Screw 35mm long, 5.5mm circumference, non locking. The Boundary Anterior Lumbar
• 90814008025407: Buttress Plate Screw 30mm long, 5.5mm circumference, non locking. The Boundary Anterior Lumbar
• 90814008025391: Buttress Plate Screw 25mm long, 5.5mm circumference, non locking. The Boundary Anterior Lumbar
• 90814008025384: Buttress Plate Screw 20mm long, 5.5mm circumference, non locking. The Boundary Anterior Lumbar
• 90814008025377: Buttress Plate 25mm long, 0 degree. The Boundary Anterior Lumbar Buttress Plate is intended to
• 90814008025360: Buttress Plate 25mm long, 8 degree. The Boundary Anterior Lumbar Buttress Plate is intended to
• 90814008025353: Buttress Plate 20mm long, 0 degree. The Boundary Anterior Lumbar Buttress Plate is intended to
• 90814008025346: Buttress Plate 20mm long, 8 degree. The Boundary Anterior Lumbar Buttress Plate is intended to
• 90814008025339: Buttress Plate 15mm long, 0 degree. The Boundary Anterior Lumbar Buttress Plate is intended to
• 90814008025322: Buttress Plate 15mm long, 8 degree. The Boundary Anterior Lumbar Buttress Plate is intended to
• 00810005663908: Lumbar Buttress Plate INSERT 1 Lid. The Boundary Anterior Lumbar Buttress Plate is intended to
• 00810005663892: Lumbar Buttress Plate INSERT 1. The Boundary Anterior Lumbar Buttress Plate is intended to stab
• 00810005663885: Lumbar Buttress Plate Case Lid. The Boundary Anterior Lumbar Buttress Plate is intended to stab
• 00810005663878: Lumbar Buttress Plate Case Base. The Boundary Anterior Lumbar Buttress Plate is intended to sta