OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500— 510(k) K031083

Substantially Equivalent

Opus Medical, Inc.

FDA 510(k) clearance K031083 for OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500, Substantially Equivalent on 2003-06-12. Applicant: Opus Medical, Inc..

Clearance details

Applicant: Opus Medical, Inc.
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 2003-04-04
Decision date: 2003-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.