ORTHO-PRO CANNULATED BONE SCREWS— 510(k) K042310

Substantially Equivalent

Ortho-Pro, LLC

FDA 510(k) clearance K042310 for ORTHO-PRO CANNULATED BONE SCREWS, Substantially Equivalent on 2004-09-16. Applicant: Ortho-Pro, LLC.

Clearance details

Applicant: Ortho-Pro, LLC
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2004-08-25
Decision date: 2004-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.