FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)— 510(k) K131591

Substantially Equivalent

Pega Medical, Inc.

FDA 510(k) clearance K131591 for FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE), Substantially Equivalent on 2013-11-27. Applicant: Pega Medical, Inc..

Clearance details

Applicant: Pega Medical, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2013-05-31
Decision date: 2013-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laval, CA

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.