510(k) K102743— ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES

Substantially Equivalent

Ortho Solutions Limited

Clearance details

Applicant: Ortho Solutions Limited
Product code: Code HWE
Advisory panel: General, Plastic Surgery
Date received: 2010-09-22
Decision date: 2011-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Prior Lake, MN, US

Adverse events under product code HWE

product code HWE

Death: 4
Injury: 448
Malfunction: 19,856
Other: 2
Total: 20,310

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.