OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS— 510(k) K983152

Substantially Equivalent

Osteonics Corp.

FDA 510(k) clearance K983152 for OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS, Substantially Equivalent on 1998-09-25. Applicant: Osteonics Corp..

Clearance details

Applicant: Osteonics Corp.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 1998-09-09
Decision date: 1998-09-25
Decision: Substantially Equivalent
Clearance type: Special
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.