K222978 is an FDA 510(k) clearance for the Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device. This device is classified as a Mesh, Surgical, Non-resorbable, Orthopedics, Reinforcement Of Ligament (Class II - Special Controls, product code QUW).
Submitted by Xiros, Ltd. (Leeds, GB). The FDA issued a Cleared decision on December 27, 2022, 90 days after receiving the submission on September 28, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300. A Non-resorbable Orthopedic Mesh Used For Reinforcement Of Soft Tissue Where Weakness Exists In Ligament Repair..
| 510(k) Number | K222978 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2022 |
| Decision Date | December 27, 2022 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | QUW - Mesh, Surgical, Non-resorbable, Orthopedics, Reinforcement Of Ligament |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | A Non-resorbable Orthopedic Mesh Used For Reinforcement Of Soft Tissue Where Weakness Exists In Ligament Repair. |