The following data is part of a premarket notification filed by Xiros Ltd with the FDA for Infinity-lock 3, Infinity-lock 5.
| Device ID | K171680 |
| 510k Number | K171680 |
| Device Name: | Infinity-Lock 3, Infinity-Lock 5 |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Xiros Ltd Springfield House, Whitehouse Lane Leeds, GB Ls197ue |
| Contact | Stephen Seed |
| Correspondent | Stephen Seed Xiros Ltd Springfield House, Whitehouse Lane Leeds, GB Ls197ue |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-06 |
| Decision Date | 2017-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060267131935 | K171680 | 000 |
| 05060267131928 | K171680 | 000 |
| 05060267132550 | K171680 | 000 |
| 05060267132543 | K171680 | 000 |