Manufacturer
Orthofix
ItalyLegal entities : Orthofix Srl
Markets : France · Germany · Italy · United States
Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 103 · PMA : 3 · class I, II, III · latest in 2026 · see on the FDA website
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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