The following data is part of a premarket notification filed by Xiros Ltd with the FDA for Xtreme-loop.
| Device ID | K191053 |
| 510k Number | K191053 |
| Device Name: | Xtreme-Loop |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Xiros Ltd Springfield House Lane, Whitehouse Lane Leeds, GB Ls17 7ue |
| Contact | Stephen Seed |
| Correspondent | Stephen Seed Xiros Ltd Springfield House Lane, Whitehouse Lane Leeds, GB Ls17 7ue |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-19 |
| Decision Date | 2019-07-17 |