OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM— 510(k) K982798

Substantially Equivalent

Osteonics Corp.

FDA 510(k) clearance K982798 for OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM, Substantially Equivalent on 1999-03-25. Applicant: Osteonics Corp..

Clearance details

Applicant: Osteonics Corp.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 1998-08-10
Decision date: 1999-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

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Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.