The following data is part of a premarket notification filed by Linvatec Corporation D/b/a Conmed Linvatec with the FDA for Y-knot Flex All-suture Anchor, W/ Two #2 (5 Metric) Hi-fi Sutures, 1.8mm.
| Device ID | K131035 |
| 510k Number | K131035 |
| Device Name: | Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | LINVATEC CORPORATION D/B/A CONMED LINVATEC 11311 Concept Boulevard Largo, FL 33773 |
| Contact | Joy Lovett |
| Correspondent | Joy Lovett LINVATEC CORPORATION D/B/A CONMED LINVATEC 11311 Concept Boulevard Largo, FL 33773 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-12 |
| Decision Date | 2013-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854606091 | K131035 | 000 |
| 10845854044735 | K131035 | 000 |
| 20653405986765 | K131035 | 000 |
| 20653405986772 | K131035 | 000 |
| 20845854050689 | K131035 | 000 |
| 20845854850654 | K131035 | 000 |
| 20845854021672 | K131035 | 000 |
| 20845854041793 | K131035 | 000 |
| 20845854042004 | K131035 | 000 |
| 20845854042028 | K131035 | 000 |
| 10845854044728 | K131035 | 000 |