Lactosorb Sheets
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K992158 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)
Lactosorb Sheets are plate, bone devices intended for use as fixation devices in trauma procedures of the midface or craniofacial skeleton. They are substantially equivalent to predicate devices and were cleared via the traditional 510(k) pathway.
The device is a Class 2 dental device with product code JEY, manufactured by Biomet, Inc., and received FDA 510(k) clearance on August 20, 1999 (K992158). It is supplied as a single or multiple component metallic bone fixation appliance and accessory intended for implantation.
Frequently asked questions
What is the intended use of Lactosorb Sheets?
Lactosorb Sheets are intended for use as fixation devices in trauma procedures of the midface or craniofacial skeleton, providing structural support during healing.
How are Lactosorb Sheets supplied for clinical use?
Lactosorb Sheets are supplied as a single or multiple component metallic bone fixation appliance and accessory, designed for implantation in surgical procedures.
Are Lactosorb Sheets reusable or single-use devices?
Lactosorb Sheets are intended for single-use implantation; as implantable fixation devices, they are not designed to be removed, resterilized, or reused after initial implantation.
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: LACTOSORB SHEETS (K992158) — FDA 510 (k) | Innolitics, K992158 FDA 510 (k) - LACTOSORB SHEETS | Biomet, Inc., LACTOSORB PLATES, MESHES, AND PANELS/SHEETS by BIOMET, INC. | FDA 510 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K992158 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K992158 24 fields · synced Sep 28, 2026