Xiros, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K230671Pitch PaSoft Tissue Reinforcement DeviceMay 31, 2023
K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceDecember 27, 2022
K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceAugust 26, 2022
K220906SECURE-LOCKJuly 22, 2022
K211563Pitch-PatchsAugust 13, 2021
K191053Xtreme-LoopJuly 17, 2019
K180243Infinity-Lock Button SystemApril 3, 2018
K171680Infinity-Lock 3, Infinity-Lock 5June 30, 2017
K151601SECURE-LOOPSeptember 9, 2015
K002172POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)August 28, 2001
K010051POLY-TAPES WITH THE FASTLOK FIXATION DEVICEJuly 13, 2001