Ultra-Drive 3
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K031280 FDA 510(k)
- FDA Product Code
- JDX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.4580 FDA 510(k)
- Regulation Number
- 888.4580 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ultra-Drive 3 is a surgical sonic instrument designed for the cutting and removal of bone and acrylic bone cement in orthopedic applications. Classified as an Instrument, Surgical, Sonic, and Accessory/Attachment, it is intended for use in orthopedic procedures where precise tissue manipulation is required.
This device is supplied as a reusable Class 2 medical instrument, regulated under FDA 510(k) clearance (K031280) and the Traditional pathway. It is intended for use in sterile surgical environments and adheres to regulatory standards outlined in 21 CFR 888.4580. The Ultra-Drive 3 is authorized for orthopedic applications and is not MRI-safe.
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: ULTRA-DRIVE 3 510 (k) K031280 - FDA.report, ULTRA-DRIVE 3 (K031280) — FDA 510(k) | Innolitics, K031280 FDA 510 (k) - ULTRA-DRIVE 3 | Biomet, Inc., Biomet Ultra-Drive 3 Surgical Technique | Manualzz
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K031280 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K031280 24 fields · synced Sep 19, 2026