FLEXIBLE REAMER, GUIDE WIRE SYSTEM— 510(k) K790307

Substantially Equivalent

3M Company

FDA 510(k) clearance K790307 for FLEXIBLE REAMER, GUIDE WIRE SYSTEM, Substantially Equivalent on 1979-02-22. Applicant: 3M Company.

Clearance details

Applicant
3M Company
Product code
Code HTO
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
White City, OR, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HTO

product code HTO
Injury
404
Malfunction
20,305
Total
20,709

Source: openFDA MAUDE database, through . 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.