K171680 is an FDA 510(k) clearance for the Infinity-Lock 3, Infinity-Lock 5. This device is classified as a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II - Special Controls, product code GAT).
Submitted by Xiros, Ltd. (Leeds, GB). The FDA issued a Cleared decision on June 30, 2017, 24 days after receiving the submission on June 6, 2017.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5000.
| 510(k) Number | K171680 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2017 |
| Decision Date | June 30, 2017 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAT - Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5000 |