WARSAW ORTHOPEDIC POINTED REAMER— 510(k) K870845

Substantially Equivalent

Warsaw Orthopedic, Inc.

FDA 510(k) clearance K870845 for WARSAW ORTHOPEDIC POINTED REAMER, Substantially Equivalent on 1987-03-11. Applicant: Warsaw Orthopedic, Inc..

Clearance details

Applicant: Warsaw Orthopedic, Inc.
Product code: Code HTO
Advisory panel: Orthopedic
Date received: 1987-03-03
Decision date: 1987-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code HTO

product code HTO

Injury: 404
Malfunction: 20,305
Total: 20,709

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.