FDA applicant
SI-BONE, Inc.
FDA records 33 decisions for SI-BONE, Inc. (Santa Clara, CA) from 2008 to 2026: 33 510(k) clearances. Most are in product codes OUR (Sacroiliac Joint Fixation) and OLO (Orthopedic Stereotaxic Instrument). Since 2016 its 510(k)s took a median of 96 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 122 predicates, 95 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided SI-BONE, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like SI-BONE, Inc.’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