LactoSorb Panels and Fasteners
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K984390 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)
LactoSorb Panels and Fasteners are bioresorbable fixation devices composed of a synthetic polylactic/polyglycolic acid copolymer. They are designed to provide temporary stabilization of bony fragments by maintaining their position during mandibular bone graft procedures.
These devices are intended for use in conjunction with rigid internal fixation in non-load bearing applications. The material is designed to degrade in vivo via hydrolysis. This device has received FDA 510(k) clearance.
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 PANELS AND FASTENERS by BIOMET, INC. | FDA 510 (k) Summary, LACTOSORB PANELS AND FASTENERS (K980927) — FDA 510 (k) | Innolitics, LACTOSORB PANELS AND FASTENERS (K984390) - FDA 510 (k), LORENZ LACTOSORB PANELS AND FASTENERS by BIOMET, INC. | FDA 510 (k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K984390 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K984390 24 fields · synced Sep 21, 2026