OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5— 510(k) K140226

Substantially Equivalent

Science For Biomaterials

FDA 510(k) clearance K140226 for OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5, Substantially Equivalent on 2014-06-03. Applicant: Science For Biomaterials.

Clearance details

Applicant: Science For Biomaterials
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2014-01-29
Decision date: 2014-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lourdes, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.