SI-Restore Sacroiliac Joint Fixation System— 510(k) K200868

Name: FDA 510(k) clearance K200868
Creator: U.S. Food and Drug Administration
Published: 2020-04-17

Substantially Equivalent

Biofusion Medical

FDA 510(k) clearance K200868 for SI-Restore Sacroiliac Joint Fixation System, Substantially Equivalent on 2020-04-17. Applicant: Biofusion Medical. Device class: 2.

Clearance details

Applicant: Biofusion Medical
Product code: Code OUR
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2020-04-01
Decision date: 2020-04-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OUR

view all

K261381 — TiLink-L SI Joint Fusion System2026-08-24
K260477 — CATAMARAN SI Joint Fusion System2026-04-08
K253488 — iFuse INTRA Ti Implant System2026-02-11
K253611 — Falco Fusion System2026-01-29
K252834 — Sacroiliac Joint Truss System (SJTS)2026-01-28

More clearances from Biofusion Medical

view all

K182919 — SI-Restore® Sacroiliac Joint Fixation System2019-01-25

Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.