OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM— 510(k) K991055

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K991055 for OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM, Substantially Equivalent on 1999-08-27. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 1999-03-30
Decision date: 1999-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.