Omnia Medical Rotary Plif System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K183659 FDA 510(k)
- FDA Product Code
- MAX 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 Omnia Medical Rotary Plif System is an orthopedic device. It is classified under the product code MAX.
The Omnia Medical Rotary Plif System is supplied by Omnia Medical, LLC, and has received FDA 510K authorization. The device is associated with the k number K183659.
Frequently asked questions
What is the Omnia Medical Rotary PLIF System used for?
The Omnia Medical Rotary PLIF System is used for orthopedic procedures, specifically posterior lumbar interbody fusion (PLIF).
Is the Omnia Medical Rotary PLIF System sterile?
The device data does not specify sterility, but it is typically expected for orthopedic devices to be supplied sterile or have sterilization instructions.
What is the regulatory status of the Omnia Medical Rotary PLIF System?
The Omnia Medical Rotary PLIF System has received FDA 510K authorization, indicated by the k number K183659, which signifies substantial equivalence to a predicate device.
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 | K183659 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Omnia Medical, Llc
Sources (1)
- FDA 510(k) K183659 24 fields · synced Sep 23, 2026