Arrowhead De, LLC

Medical device manufacturer in Peachtree City, GA.

3510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K200123Accessories for the SixFix® Hexapod FixatorKTT · Traditional 09/22/2020SE
K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)KTT · Traditional 05/14/2019SE
K162032Arrowhead Mini-Rail FixatorKTT · Traditional 02/21/2017SE

Recalls

RecallProductInitiated
Z-2958-2026 Class IIArrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530…Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following… 06/23/2026Open, Classified