Home › Si-Bone Inc. › iFuse Bedrock Granite Implant System
iFuse Bedrock Granite Implant System
Si-Bone Inc. · Model 095120BG · UDI-DI 00810055523948
1
510(k) clearances
1,406
Adverse events (5 deaths)
1
Recalls
154
Facilities
Description
9.5 mm x 120 mm iFuse Bedrock Granite Implant
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.