ACUTE BONE SCREW— 510(k) K061206

Substantially Equivalent

Acute Innovations, LLC

FDA 510(k) clearance K061206 for ACUTE BONE SCREW, Substantially Equivalent on 2006-06-19. Applicant: Acute Innovations, LLC.

Clearance details

Applicant: Acute Innovations, LLC
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2006-05-01
Decision date: 2006-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hillsboro, OR, 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.