The following data is part of a premarket notification filed by Xiros Ltd with the FDA for Infinity-lock Button System.
| Device ID | K180243 |
| 510k Number | K180243 |
| Device Name: | Infinity-Lock Button System |
| Classification | Washer, Bolt Nut |
| Applicant | Xiros Ltd Springfield House, Whitehouse Lane Leeds, GB Ls17 7ue |
| Contact | Stephen Seed |
| Correspondent | Stephen Seed Xiros Ltd Springfield House, Whitehouse Lane Leeds, GB Ls17 7ue |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-29 |
| Decision Date | 2018-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060267131836 | K180243 | 000 |