Vertex
GUDID 00810005661089
Implant is 18mm bridge staple, 18mm x 18mm legs. 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.
Orthopaedic bone staple, non-adjustable, sterile| Primary Device ID | 00810005661089 |
| NIH Device Record Key | 7eec509d-5a16-4b84-ba64-a94cc7c164d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vertex |
| Version Model Number | STK-18-18-18 |
| 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
Device Dimensions
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
| Length | 18 Millimeter |
| Depth | 18 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810005661089 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182943
FDA Product Code
| JDR | Staple, Fixation, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
Moist Heat or Steam Sterilization
[00810005661089]
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 |
Trademark Results [Vertex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERTEX 98620698 not registered Live/Pending |
Amer Sports Canada Inc. 2024-06-26 |
 VERTEX 98418366 not registered Live/Pending |
Albaugh, LLC 2024-02-23 |
 VERTEX 98418165 not registered Live/Pending |
Eos Positioning Systems Inc. 2024-02-23 |
 VERTEX 98283922 not registered Live/Pending |
SMB DOLLAR INC. 2023-11-24 |
 VERTEX 98003838 not registered Live/Pending |
Guangdong Xupai New Energy Co., LTD 2023-05-18 |
 VERTEX 97926020 not registered Live/Pending |
BOSU Fitness, LLC 2023-05-08 |
 VERTEX 97842957 not registered Live/Pending |
Tony Wang 2023-03-16 |
 VERTEX 97810328 not registered Live/Pending |
Neptune Medical Inc. 2023-02-24 |
 VERTEX 97717621 not registered Live/Pending |
Alliance Sports Group, L.P. 2022-12-14 |
 VERTEX 97649858 not registered Live/Pending |
Alliance Sports Group, L.P. 2022-10-26 |
 VERTEX 97641291 not registered Live/Pending |
SeeScan, Inc. 2022-10-20 |
 VERTEX 97563091 not registered Live/Pending |
Boxcar USA LLC 2022-08-24 |
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