Identifiers
- 510(k) Number
- K031659 FDA 510(k)
- FDA Product Code
- JEY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4760 FDA 510(k)
- Regulation Number
- 872.4760 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Universal Neuro System is a bone plate device classified under FDA 510(k) clearance K031659. It is substantially equivalent to a predicate device and falls under the medical specialty of dental, as indicated by the openFDA device name 'Plate, Bone' and the advisory committee designation DE (Dental).
The device is manufactured by Stryker Instruments and is supplied as a reusable or single-use implant based on clinical application, though sterility, MRI safety, sizes, storage conditions, and specific usage settings are not detailed in the provided data. Regulatory authorization is limited to the FDA 510(k) clearance, with no additional approvals or markings stated.
Frequently asked questions
What is the Universal Neuro System used for?
The Universal Neuro System is a bone plate device indicated for dental applications, as classified under the medical specialty of Dental and the openFDA device name 'Plate, Bone'.
Is the Universal Neuro System reusable or single-use?
The device is supplied as either reusable or single-use depending on the clinical application, as stated in the description, though specific use cases for each are not detailed in the provided data.
What regulatory authorization does the Universal Neuro System have?
The Universal Neuro System has FDA 510(k) clearance under K031659, determined to be substantially equivalent to a predicate device, with no additional approvals or markings mentioned in the data.
Who manufactures the Universal Neuro System and where are they located?
The Universal Neuro System is manufactured by Stryker Instruments, located at 4100 E. Milham Ave., Kalamazoo, MI 49001, United States.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K031659 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Instruments
Sources (1)
- FDA 510(k) K031659 24 fields · synced Sep 23, 2026