MONSTER SCREW SYSTEM— 510(k) K124027

Substantially Equivalent

Apogee Orthosolutions

FDA 510(k) clearance K124027 for MONSTER SCREW SYSTEM, Substantially Equivalent on 2013-04-05. Applicant: Apogee Orthosolutions.

Clearance details

Applicant: Apogee Orthosolutions
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2012-12-28
Decision date: 2013-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chesterland, OH, 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.