Identity
- Trade Name
- Vertex FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Instrument: sizing guide body is 08-10 (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. FDA UDI
- Model / Reference
- STK-1000T-001 FDA UDI
- Description
- Instrument: sizing guide body is 08-10 (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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810005667258 FDA UDI
- 510(k) Number
- K182943 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General internal orthopaedic fixation system implantation kit
Vertex by Nvision Biomedical Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K182943 also covers:
- Vertex — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Vertex — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Vertex — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Vertex — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Vertex — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Vertex — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Vertex — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Vertex — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Vertex — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Vertex — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Vertex — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Vertex — NVISION BIOMEDICAL TECHNOLOGIES, INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nvision Biomedical Technologies, Inc
Sources (1)
- FDA UDI 6d6ff857-6291-4a86-8100-3e26e6677f1f 35 fields · synced Jun 8, 2026