Acumed Lower Extremity Congruent Plate System
FDA 510(k)Class II (US FDA 510(k))
by Acumed, LLC
Identifiers
- 510(k) Number
- K033639 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 Acumed Lower Extremity Congruent Plate System is an orthopedic fixation device designed for internal stabilization of bone fractures, fusions, and osteotomies in the lower extremities. It features congruent plates and screws tailored to the anatomical contours of the phalanges, metatarsals, tarsals, tibia, and fibula, ensuring precise alignment and secure fixation during surgical reconstruction or repair.
This system is supplied sterile and intended for single-use in orthopedic procedures. It is classified under product code HWC and has received FDA 510(k) clearance as substantially equivalent to a predicate device. The plates and screws are engineered for compatibility with standard surgical techniques, and their design adheres to regulatory standards for orthopedic hardware. Storage and handling follow standard sterile medical device protocols to maintain integrity and functionality.
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: Congruent Plating System - Acumed, Acumed | Surgical Orthopedic Fracture Fixation Solutions, Acumed Lower Extremity Congruent Plate System, Acumed Lower Extremity Congruent Plate System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033639 | Class II | Active |
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Manufacturer
- Manufacturer
- Acumed, LLC
Sources (1)
- FDA 510(k) K033639 24 fields · synced Sep 20, 2026