Litho 60 +2 more models

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K242251

Identifiers

510(k) Number: K242251 FDA 510(k)
FDA Product Code: GEX FDA 510(k)
Models / Variants: Litho 60 FDA 510(k)EUDAMED
Litho 100 FDA 510(k)EUDAMED
Litho 150 FDA 510(k)EUDAMED

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 Litho 60; Litho 100; and Litho 150 are bone cutting and shaping instruments designed for orthopaedic and plastic surgery applications. These devices are intended for precise osteotomy, bone resection, and contouring procedures, facilitating surgical reconstruction and correction of skeletal structures.

Supplied sterile and intended for single-use, these instruments are classified under product code GEX and are authorised under FDA 510K clearance and MDR compliance. They are manufactured by Quanta System Spa and are intended for use in controlled surgical environments, adhering to strict regulatory standards for medical devices.

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

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K242251	Class II	Active

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Manufacturer

Manufacturer: Quanta System Spa

Sources (2)

FDA 510(k) K242251 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 18, 2026