Vertex

GUDID 00810005667265

Instrument: sizing guide body is 16-18 (multiple use). The Vertex Nitinol Staple System consists of a series of nickel titanium alloy staple implants and the instruments necessary for the treatment of pathologies of the foot and ankle. The Vertex bone staples are made from superelastic nitinol that does not require cold storage or heating.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00810005667265
• NIH Device Record Key: a63ca897-36a4-4f10-9d6c-a66999e2d32a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vertex
• Version Model Number: STK-1000T-003
• 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: false
• 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
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810005667265 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182943

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[00810005667265]

Moist Heat or Steam Sterilization

[00810005667265]

Moist Heat or Steam Sterilization

[00810005667265]

Moist Heat or Steam Sterilization

[00810005667265]

Moist Heat or Steam Sterilization

[00810005667265]

Moist Heat or Steam Sterilization

[00810005667265]

Moist Heat or Steam Sterilization

[00810005667265]

Moist Heat or Steam Sterilization

[00810005667265]

Moist Heat or Steam Sterilization

[00810005667265]

Moist Heat or Steam Sterilization

[00810005667265]

Moist Heat or Steam Sterilization

[00810005667265]

Moist Heat or Steam Sterilization

[00810005667265]

Moist Heat or Steam Sterilization

[00810005667265]

Moist Heat or Steam Sterilization

[00810005667265]

Moist Heat or Steam Sterilization

[00810005667265]

Moist Heat or Steam Sterilization

[00810005667265]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-05
• Device Publish Date: 2020-12-28

On-Brand Devices [Vertex]

• 00810005667289: Instrument: sizing guide body is 12-14 (multiple use). The Vertex Nitinol Staple System consis
• 00810005667272: Instrument: sizing guide body is 20-25 (multiple use). The Vertex Nitinol Staple System consis
• 00810005667265: Instrument: sizing guide body is 16-18 (multiple use). The Vertex Nitinol Staple System consis
• 00810005667258: Instrument: sizing guide body is 08-10 (multiple use). The Vertex Nitinol Staple System consis
• 00810005665162: Implant is 20mm bridge staple, 20mm x 20mm legs. The Vertex Nitinol Staple System consists of a
• 00810005665155: Implant is 20mm bridge staple, 18mm x 18mm legs. The Vertex Nitinol Staple System consists of a
• 00810005661096: Implant is 20mm bridge staple, 14mm x 14mm legs. The Vertex Nitinol Staple System consists of a
• 00810005661089: Implant is 18mm bridge staple, 18mm x 18mm legs. The Vertex Nitinol Staple System consists of a
• 00810005661072: Implant is 18mm bridge staple, 14mm x 14mm legs. The Vertex Nitinol Staple System consists of a
• 00810005661065: Implant is 16mm bridge staple, 16mm x 16mm legs. The Vertex Nitinol Staple System consists of a
• 00810005661058: Implant is 16mm bridge staple, 14mm x 14mm legs. The Vertex Nitinol Staple System consists of a
• 00810005661041: Implant is 14mm bridge staple, 14mm x 14mm legs. The Vertex Nitinol Staple System consists of a
• 00810005661034: Implant is 12mm bridge staple, 12mm x 12mm legs. The Vertex Nitinol Staple System consists of a
• 00810005661027: Implant is 10mm bridge staple, 10mm x 10mm legs. The Vertex Nitinol Staple System consists of a
• 00810005661010: Implant is 8mm bridge staple, 8mm x 8mm legs. The Vertex Nitinol Staple System consists of a se
• 00810005661003: Instrument: Staple Distractor. The Vertex Nitinol Staple System consists of a series of nickel
• 00810005665346: Instrument: 2.5mm Drill. The Vertex Nitinol Staple System consists of a series of nickel titan
• 00810005665339: Instrument: 2.3mm Drill. The Vertex Nitinol Staple System consists of a series of nickel titan
• 00810005665322: Instrument: 2.1mm Drill. The Vertex Nitinol Staple System consists of a series of nickel titan
• 00810005665315: Instrument: 1.9mm Drill. The Vertex Nitinol Staple System consists of a series of nickel titan
• 00810005665308: Instrument: 1.7mm Drill. The Vertex Nitinol Staple System consists of a series of nickel titan
• 00810005665278: Instrument: Tamp. The Vertex Nitinol Staple System consists of a series of nickel titanium all
• 00810005663946: Vertex Reusable Tray Caddy Lid. The Vertex Nitinol Staple System consists of a series of nickel
• 00810005663939: Vertex Reusable Tray Caddy Base. The Vertex Nitinol Staple System consists of a series of nicke
• 00810005663922: Vertex Reusable Tray Lid. The Vertex Nitinol Staple System consists of a series of nickel titan
• 00810005663915: Vertex Reusable Tray Base. The Vertex Nitinol Staple System consists of a series of nickel tita
• 00810135962834: Instrument: 3.0mm Drill. The Vertex Nitinol Staple System consists of a series of nickel titan