Xiros Ltd
YEADON Leeds, GB
XIROS LTD appears in FDA device records in YEADON Leeds, GB. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Xiros Ltd between 2001 and 2023. The busiest year on record is 2022, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 2 |
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K230671 | Pitch PaSoft Tissue Reinforcement Device | FTL | Substantially Equivalent | |
| K222978 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | QUW | Substantially Equivalent | |
| K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | FTL | Substantially Equivalent | |
| K220906 | SECURE-LOCK | HTY | Substantially Equivalent | |
| K211563 | Pitch-Patchs | FTL | Substantially Equivalent | |
| K191053 | Xtreme-Loop | MBI | Substantially Equivalent | |
| K180243 | Infinity-Lock Button System | HTN | Substantially Equivalent | |
| K171680 | Infinity-Lock 3, Infinity-Lock 5 | GAT | Substantially Equivalent | |
| K151601 | SECURE-LOOP | MBI | Substantially Equivalent | |
| K002172 | POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) | GAT | Substantially Equivalent | |
| K010051 | POLY-TAPES WITH THE FASTLOK FIXATION DEVICE | JDR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8044102 | 3013299874 | XIROS LTD | SPRINGFIELD HOUSE, YEADON Leeds LS19 7UE GB | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HWBExtractor
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- GDGHook, Surgical, General & Plastic Surgery
- OWXMesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
- QUWMesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
- FTLMesh, Surgical, Polymeric
- OJHOrthopedic Tray
- HWQPasser
- HTYPin, Fixation, Smooth
- HXBProbe
- HXJStaple Driver
- JDRStaple, Fixation, Bone
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- HTNWasher, Bolt Nut
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1501-06 | Neoligaments Staple Impactor, 8 mm Staple Impactor: 202-3010 | The impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination after cleaning and may not be effectively sterilized by the recommended hospital sterilization cycles. | Terminated | ||
| Z-1500-06 | Neoligaments Staple Impactor, 6 mm Staple Impactor: 202-3001 | The impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination after cleaning and may not be effectively sterilized by the recommended hospital sterilization cycles. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain