PRIMADO2 Total Surgical System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132264 FDA 510(k)
- FDA Product Code
- HBC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4360 FDA 510(k)
- Regulation Number
- 882.4360 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Primado2 Total Surgical System is a motor, drill, electric device classified under neurology specialty. It is a second-generation electric total surgical system designed for use in surgical procedures.
The system received FDA 510(k) clearance (K132264) as substantially equivalent to a predicate device. It is manufactured by Nakanishi Inc. and is intended for use in clinical settings where powered surgical drilling is required.
Frequently asked questions
What is the Primado2 Total Surgical System used for?
The Primado2 Total Surgical System is intended for use in surgical procedures where powered surgical drilling is required, as it is a motor, drill, electric device designed for such clinical applications.
How is the Primado2 Total Surgical System supplied or powered?
The system is an electric device, meaning it is powered electrically and designed as a motor and drill for surgical use, though specific power supply details are not provided in the device data.
Is the Primado2 Total Surgical System reusable or single-use?
The device data does not specify whether the Primado2 Total Surgical System is reusable or single-use; therefore, reuse status cannot be determined from the provided information.
What regulatory clearance does the Primado2 Total Surgical System have?
The Primado2 Total Surgical System received FDA 510(k) clearance under submission K132264, determined to be substantially equivalent to a predicate device.
What medical specialty is the Primado2 Total Surgical System associated with?
The device is classified under the neurology specialty, as indicated by the medical specialty description and advisory committee designation in the device data.
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: Primado2 - SURGITECH, NSK PRIMADO2 OPERATION MANUAL Pdf Download | ManualsLib, Products｜NSK-Nakanishi Surgical International, NSK PRIMADO 2 OPERATION MANUAL Pdf Download | ManualsLib, User Guides｜NSK-Nakanishi Surgical Europe
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132264 | Class II | Active |
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Manufacturer
- Manufacturer
- Nakanishi Inc.
- FDA Applicant
- Nakanishi, Inc.
Sources (1)
- FDA 510(k) K132264 24 fields · synced Sep 25, 2026