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Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K192600

by Quanta System Spa

Identifiers

510(k) Number
K192600 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cyber Ho 60, Cyber Ho 100, Litho 100, and Litho 60 are orthopedic fixation devices classified under the product code GEX (General, Plastic Surgery). These devices are designed for internal fixation of long bone fractures, providing mechanical stability through the use of intramedullary nails and related hardware to facilitate proper bone alignment and healing.

Supplied as sterile, single-use devices, these intramedullary nails are intended for use in orthopedic surgical settings. Each model (Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60) is engineered for specific bone diameters and lengths, ensuring compatibility with clinical requirements. Authorized under FDA 510(k) clearance (K192600) and MDR compliance, they are manufactured by Quanta System Spa, Italy, and distributed with appropriate sterile packaging for surgical use.

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 (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Quanta System Spa

Sources (2)

  • FDA 510(k) K192600 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026