Lactosorb Tibial L-15 Screw and Washer
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K033233 FDA 510(k)
- FDA Product Code
- HWC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Lactosorb Tibial L-15 Screw and Washer is an orthopedic device designed for surgical fixation. It is intended to provide stabilization within the tibial region during orthopedic procedures.
This device is supplied by Biomet, Inc. and has received FDA 510k clearance. It is categorized under product code HWC and is subject to the regulatory requirements associated with its orthopedic classification.
Frequently asked questions
What is the primary purpose of the Lactosorb Tibial L-15 Screw and Washer?
This device is specifically engineered for surgical fixation. It is intended to provide necessary stabilization within the tibial region during orthopedic procedures.
Who is the manufacturer of this orthopedic fixation device?
The Lactosorb Tibial L-15 Screw and Washer is manufactured by Biomet, Inc., located in Warsaw, Indiana.
What is the regulatory status of this device?
The device has received FDA 510k clearance under K-number K033233. It is categorized under product code HWC and is subject to the regulatory requirements associated with its orthopedic classification.
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 | K033233 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K033233 24 fields · synced Sep 23, 2026