FDA applicant
Orthosonics, Ltd.
FDA records 4 decisions for Orthosonics, Ltd. (Ashburton, Devon, GB) from 2002 to 2010: 4 510(k) clearances. Most are in product codes JDX (Instrument, Surgical, Sonic And…) and LZV (System, Cement Removal Extraction). Its devices cite 12 predicates, 4 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Orthosonics, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Orthosonics, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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