FDA applicant
Silony Medical GmbH
FDA records 13 decisions for Silony Medical GmbH (Leinfelden-Echterdingen, DE) from 2017 to 2026: 13 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and OLO (Orthopedic Stereotaxic Instrument). Since 2016 its 510(k)s took a median of 150 days from receipt to decision, against 104 for FDA’s reviews in the same codes and years. Its devices cite 27 predicates, 6 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 Silony Medical GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Silony Medical GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report