The following data is part of a premarket notification filed by Xiros Ltd with the FDA for Secure-loop.
| Device ID | K151601 |
| 510k Number | K151601 |
| Device Name: | SECURE-LOOP |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| 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 | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-12 |
| Decision Date | 2015-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060267131515 | K151601 | 000 |
| 05060267131423 | K151601 | 000 |
| 05060267131430 | K151601 | 000 |
| 05060267131447 | K151601 | 000 |
| 05060267131454 | K151601 | 000 |
| 05060267131461 | K151601 | 000 |
| 05060267131478 | K151601 | 000 |
| 05060267131485 | K151601 | 000 |
| 05060267131492 | K151601 | 000 |
| 05060267131508 | K151601 | 000 |
| 05060267131416 | K151601 | 000 |