Vail ALIF Buttress Plate System BP1220

GUDID 00195860010778

Dia 5.5 x 20mm Screw

Evolution Spine LLC

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00195860010778
• NIH Device Record Key: bbe20786-e8a9-44e7-a3c3-f6dbd32ce0b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vail ALIF Buttress Plate System
• Version Model Number: BP1220
• Catalog Number: BP1220
• Company DUNS: 116940934
• Company Name: Evolution Spine LLC
• Device Count: 1
• DM Exempt: false
• 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: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com

Device Dimensions

• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195860010778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180755

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00195860010778]

Moist Heat or Steam Sterilization

[00195860010778]

Moist Heat or Steam Sterilization

[00195860010778]

Moist Heat or Steam Sterilization

[00195860010778]

Moist Heat or Steam Sterilization

[00195860010778]

Moist Heat or Steam Sterilization

[00195860010778]

Moist Heat or Steam Sterilization

[00195860010778]

Moist Heat or Steam Sterilization

[00195860010778]

Moist Heat or Steam Sterilization

[00195860010778]

Moist Heat or Steam Sterilization

[00195860010778]

Moist Heat or Steam Sterilization

[00195860010778]

Moist Heat or Steam Sterilization

[00195860010778]

Moist Heat or Steam Sterilization

[00195860010778]

Moist Heat or Steam Sterilization

[00195860010778]

Moist Heat or Steam Sterilization

[00195860010778]

Moist Heat or Steam Sterilization

[00195860010778]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-21
• Device Publish Date: 2021-06-12

On-Brand Devices [Vail ALIF Buttress Plate System]

• 00195860010839: Buttress Plate Caddy
• 00195860010822: Buttress Tap
• 00195860010815: Buttress Cover Turner Driver
• 00195860010808: Buttress Screwdriver
• 00195860010792: Buttress Inserter / Awl
• 00195860010785: Dia 5.5 x 25mm Screw
• 00195860010778: Dia 5.5 x 20mm Screw
• 00195860010761: 26mm 30 Deg Buttress Plate
• 00195860010754: 24mm 30 Deg Buttress Plate
• 00195860010747: 22mm 30 Deg Buttress Plate
• 00195860010730: 20mm 30 Deg Buttress Plate
• 00195860010723: 26mm 25 Deg Buttress Plate
• 00195860010716: 24mm 25 Deg Buttress Plate
• 00195860010709: 22mm 25 Deg Buttress Plate
• 00195860010693: 20mm 25 Deg Buttress Plate
• 00195860010686: 26mm 20 Deg Buttress Plate
• 00195860010679: 24mm 20 Deg Buttress Plate
• 00195860010662: 22mm 20 Deg Buttress Plate
• 00195860010655: 20mm 20 Deg Buttress Plate
• 00195860010648: 26mm 6 Deg Buttress Plate
• 00195860010631: 24mm 6 Deg Buttress Plate
• 00195860010624: 22mm 6 Deg Buttress Plate
• 00195860010617: 20mm 6 Deg Buttress Plate