Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list SI-BONE with 33 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Sep 23, 2026: iFuse Granite Onyx™ Implant System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 23, 2026 | iFuse Granite Onyx™ Implant SystemK262067 · NKB | 510(k) clearances |
| Aug 21, 2026 | iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)Class II · The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, ster | Device recalls |
| Feb 11, 2026 | iFuse INTRA Ti™ Implant SystemK253488 · OUR | 510(k) clearances |
| Oct 9, 2025 | iFuse Bedrock Granite Implant SystemK253094 · OUR | 510(k) clearances |
| Sep 15, 2025 | iGPS Navigation InstrumentsK251780 · OLO | 510(k) clearances |
| Aug 19, 2024 | iFuse TORQ TNT™ Implant SystemK241504 · OUR | 510(k) clearances |
| Jul 2, 2024 | iFuse TORQ® Implant SystemK241574 · OUR | 510(k) clearances |
| Feb 23, 2024 | Navigation Tracking InstrumentsK232800 · OLO | 510(k) clearances |
| Jan 26, 2024 | iFuse Bedrock Granite® Implant SystemK233508 · OUR | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
