510(k) K203247 · OUR Sacroiliac Joint Fixation
iFuse-TORQ Implant System
| Applicant | SI-BONE, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Feb 25, 2021 |
| Received | Nov 4, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203247
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2026 | SI-BONE, Inc. iFuse TORQ Implant System
Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm) Open, Classified |
OUR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.