Identifiers
- 510(k) Number
- K170074 FDA 510(k)
- FDA Product Code
- ODP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3080 FDA 510(k)
- Regulation Number
- 888.3080 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nvc is an orthopedic medical device designed for surgical use. It functions as an implant intended to support orthopedic procedures.
This device is supplied by Nvision Biomedical Technologies, LLC and has received FDA 510k authorization. It is classified under product code ODP and is subject to the regulatory requirements associated with its clearance.
Frequently asked questions
What is the primary function of the Nvc device?
The Nvc is an orthopedic medical device designed for surgical use. It functions as an implant intended to provide support during orthopedic procedures.
What is the regulatory status of the Nvc implant?
The Nvc has received FDA 510k authorization under K number K170074. It is classified under product code ODP and is subject to the regulatory requirements associated with this clearance.
Who is the manufacturer of the Nvc orthopedic device?
The Nvc is supplied by Nvision Biomedical Technologies, LLC, which is located in San Antonio, Texas.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: About - NVISION Biomedical Technologies, NVISION Biomedical Technologies, NVision Biomedical Technologies, Inc. | D&B Business Directory, NVISION Biomedical Technologies™ - LinkedIn
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170074 | Class II | Active |
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Manufacturer
- Manufacturer
- Nvision Biomedical Technologies, Inc
- FDA Applicant
- Nvision Biomedical Technologies, LLC
Sources (1)
- FDA 510(k) K170074 24 fields · synced Sep 26, 2026