OPUS SPINAL SYSTEM— 510(k) K993402

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K993402 for OPUS SPINAL SYSTEM, Substantially Equivalent on 1999-12-20. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 1999-10-08
Decision date: 1999-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.