Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System— 510(k) K232605

Substantially Equivalent

Lesspine Innovations

FDA 510(k) clearance K232605 for Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System, Substantially Equivalent on 2023-09-28. Applicant: Lesspine Innovations.

Clearance details

Applicant: Lesspine Innovations
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2023-08-28
Decision date: 2023-09-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Malden, MA, US

Download summary PDF View on FDA.gov ↗

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.