OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY— 510(k) K984375

Substantially Equivalent

Osteonics Corp.

FDA 510(k) clearance K984375 for OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY, Substantially Equivalent on 1999-04-30. Applicant: Osteonics Corp..

Clearance details

Applicant: Osteonics Corp.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1998-12-07
Decision date: 1999-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

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Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.