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 |