Xiros, Ltd.
FDA 510(k) & PMA Approved Devices — 8 products
Total Devices8
Categories6
Latest FDA decision2023-05-31
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K230671 | Pitch PaSoft Tissue Reinforcement Device | FTL | 2023-05-31 | View |
| 510(k) | K222978 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | QUW | 2022-12-27 | View |
| 510(k) | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | FTL | 2022-08-26 | View |
| 510(k) | K220906 | SECURE-LOCK | HTY | 2022-07-22 | View |
| 510(k) | K211563 | Pitch-Patchs | FTL | 2021-08-13 | View |
| 510(k) | K191053 | Xtreme-Loop | MBI | 2019-07-17 | View |
| 510(k) | K180243 | Infinity-Lock Button System | HTN | 2018-04-03 | View |
| 510(k) | K171680 | Infinity-Lock 3, Infinity-Lock 5 | GAT | 2017-06-30 | View |
No matching devices.
Related Clinical Trials
NCT05264389Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) ReconstructionACTIVE_NOT_RECRUITINGNCT05906004Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator CuffRECRUITINGNCT05304819PMCF Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon RepairCOMPLETED