Arrowhead DE LLC

FDA Regulatory Profile

Arrowhead DE LLC appears in FDA public data with 1 recall, 3 510(k) clearances, 5 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2958-2026, Class II) was initiated on June 23, 2026. Its most recent 510(k) clearance was granted on September 22, 2020.

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2958-2026Class IIArrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-June 23, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K200123Accessories for the SixFix® Hexapod FixatorSeptember 22, 2020
K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)May 14, 2019
K162032Arrowhead Mini-Rail FixatorFebruary 21, 2017