Data / Medical devices / United Kingdom / Xiros Ltd
Xiros Ltd: FDA-registered device maker in YEADON Leeds, United Kingdom, 9 510(k) clearances
Xiros Ltd is registered with the FDA (registration 8044102) in YEADON Leeds, United Kingdom. It lists 13 device types. The FDA files 9 510(k) clearances under its listings, the newest dated May 31, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 8044102
- FEI number
- 3013299874
- Address
- Springfield House Whitehouse Lane, YEADON Leeds, United Kingdom, LS19 7UE
- Owner or operator
- XIROS LTD (9001185)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 12, 2004
- Registered through
- 2026
- Brand names listed
- 10050 SIC Graft, 102-1005 Poly-Tape 5 mm x 500 mm, 102-1080 Poly-Tape 10 mm x 800 mm, 102-1081 Poly-Tape 15 mm x 800 mm, 102-1082 Poly-Tape 20 mm x 800 mm, 102-1083 Poly-Tape 30 mm x 800 mm, 102-1086 Poly-Tape 5 mm x 800 mm, 102-1087 Poly-Tape 7 mm x 800 mm and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Extractor | HWB | 1 | Manufacturer | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Manufacturer | accessdata.fda.gov |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon | OWX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament | QUW | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Orthopedic Tray | OJH | 1 | Manufacturer | accessdata.fda.gov |
| Passer | HWQ | 1 | Manufacturer | accessdata.fda.gov |
| Probe | HXB | 1 | Manufacturer | accessdata.fda.gov |
| Staple Driver | HXJ | 1 | Manufacturer | accessdata.fda.gov |
| Staple, Fixation, Bone | JDR | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Manufacturer | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 31, 2023 | K230671 | Pitch PaSoft Tissue Reinforcement Device | FTL | Substantially Equivalent | Xiros, Ltd. | accessdata.fda.gov |
| December 27, 2022 | K222978 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | QUW | Substantially Equivalent | Xiros, Ltd. | accessdata.fda.gov |
| August 26, 2022 | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | FTL | Substantially Equivalent | Xiros, Ltd. | accessdata.fda.gov |
| August 13, 2021 | K211563 | Pitch-Patchs | FTL | Substantially Equivalent | Xiros, Ltd. | accessdata.fda.gov |
| April 3, 2018 | K180243 | Infinity-Lock Button System | HTN | Substantially Equivalent | Xiros, Ltd. | accessdata.fda.gov |
| June 30, 2017 | K171680 | Infinity-Lock 3, Infinity-Lock 5 | GAT | Substantially Equivalent | Xiros, Ltd. | accessdata.fda.gov |
| September 9, 2015 | K151601 | SECURE-LOOP | MBI | Substantially Equivalent | Xiros, Ltd. | accessdata.fda.gov |
| July 13, 2001 | K010051 | POLY-TAPES WITH THE FASTLOK FIXATION DEVICE | JDR | Substantially Equivalent | Xiros Plc | accessdata.fda.gov |
| October 15, 1991 | K913461 | FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM | JDR | Substantially Equivalent | Neoligaments, Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 17, 2006 | 35828 | Not yet classified | Terminated | Neoligaments Staple Impactor, 6 mm Staple Impactor: | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Passer
- All makers of Extractor
- All makers of Mesh, Surgical, Polymeric
- All makers of Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
- All makers of Hook, Surgical, General & Plastic Surgery
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
Updated May 31, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.