Ace Universal Reconstruction Plate
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K930592 FDA 510(k)
- FDA Product Code
- HRS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ace Universal Reconstruction Plate is an orthopedic device. It is a type of plate used in reconstruction procedures.
The Ace Universal Reconstruction Plate is supplied with FDA 510K authorizations. It has a product code of HRS and is classified as substantially equivalent. The device has a specific clearance type and is manufactured by Ace Medical Co.
Frequently asked questions
What is the Ace Universal Reconstruction Plate used for?
The Ace Universal Reconstruction Plate is used in orthopedic reconstruction procedures, providing a specific solution for patients requiring this type of intervention.
Is the Ace Universal Reconstruction Plate supplied sterile?
The description does not specify the sterility of the device, but it is classified as substantially equivalent with a traditional clearance type.
What is the regulatory status of the Ace Universal Reconstruction Plate?
The device has FDA 510K authorizations, indicating it has been cleared through the 510K process as substantially equivalent 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. Sources consulted: ACE UNIVERSAL RECONSTRUCTION PLATE (K930592) — FDA 510 (k) | Innolitics, Ace Medical Co. - 17 FDA 510 (k) Orthopedic Devices (Since 1987), ACE RECONSTRUCTIVE PLATE (K905595) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K930592 | Class II | Active |
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Manufacturer
- Manufacturer
- Ace Medical Co.
Sources (1)
- FDA 510(k) K930592 24 fields · synced Sep 21, 2026