MCCONNELL REAMER GUIDE— 510(k) K885100

Substantially Equivalent

Mcconnell Orthopedic

FDA 510(k) clearance K885100 for MCCONNELL REAMER GUIDE, Substantially Equivalent on 1989-01-13. Applicant: Mcconnell Orthopedic.

Clearance details

Applicant: Mcconnell Orthopedic
Product code: Code HTO
Advisory panel: Orthopedic
Date received: 1988-12-12
Decision date: 1989-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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.