Integrity-SI® Fusion System— 510(k) K230226

Name: FDA 510(k) clearance K230226
Creator: U.S. Food and Drug Administration
Published: 2023-09-21

Substantially Equivalent

OsteoCentric Technologies

FDA 510(k) clearance K230226 for Integrity-SI® Fusion System, Substantially Equivalent on 2023-09-21. Applicant: OsteoCentric Technologies. Device class: 2.

Clearance details

Applicant: OsteoCentric Technologies
Product code: Code OUR
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2023-01-27
Decision date: 2023-09-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Logan, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OUR

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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 OsteoCentric Technologies

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K251913 — OsteoCentric® UnifiMI® TCS Plating System2025-08-16
K250494 — The OsteoCentric Bone Plate and Screw System2025-03-18
K242691 — OsteoCentric Technologies Cannulated Fasteners and Nuts2024-10-09
K230242 — OsteoCentric Dental Implant System2023-10-05
K230595 — OsteoCentric ACL Fixation System2023-06-29

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.