K902819

Substantially Equivalent

LAMINECTOMY ROGEUR

Applicant: Ruggles Corp.
Product code: LXH
Advisory panel: Orthopedic
Date received: 1990-06-27
Decision date: 1990-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: No. Quincy, MA, US

Adverse events under product code LXH

product code LXH

Death: 11
Injury: 2,218
Malfunction: 31,318
Total: 33,547

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.