FDA applicant
Bonebridge AG
FDA records 10 decisions for Bonebridge AG (Zug, CH) from 2021 to 2026: 10 510(k) clearances. All are in product code HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 84 days from receipt to decision, against 93 for FDA’s reviews in the same codes and years. Its devices cite 52 predicates, 13 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 Bonebridge AG’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Bonebridge AG’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