The following data is part of a premarket notification filed by Xiros Ltd with the FDA for Poly-tape/infinity-lock Soft Tissue Reinforcement Device.
| Device ID | K220091 |
| 510k Number | K220091 |
| Device Name: | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Xiros Ltd Springfield House Lane, Whitehouse Lane Leeds, GB LS17 7UE |
| Contact | Steve Curran |
| Correspondent | Steve Curran Xiros Ltd Springfield House Lane, Whitehouse Lane Leeds, GB LS17 7UE |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-12 |
| Decision Date | 2022-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060267132567 | K220091 | 000 |
| 05060267132536 | K220091 | 000 |
| 05060267132529 | K220091 | 000 |
| 05060267132512 | K220091 | 000 |
| 05060267132505 | K220091 | 000 |
| 05060267132499 | K220091 | 000 |