K930339

Substantially Equivalent

REAMER BIT

Applicant: Neoligaments, Ltd.
Product code: HTW
Advisory panel: Orthopedic
Date received: 1993-01-25
Decision date: 1993-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leeds, GB

Adverse events under product code HTW

product code HTW

Injury: 882
Malfunction: 8,544
Other: 3
Total: 9,429

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.