PHALINX Hammertoe System— 510(k) K150252

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K150252 for PHALINX Hammertoe System, Substantially Equivalent on 2015-04-29. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2015-02-03
Decision date: 2015-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, 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.