The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Y-knot Rc All-suture Anchor, 2.8mm - Double Loaded And Triple Loaded W/ #2 Hifi Sutures.
| Device ID | K133224 |
| 510k Number | K133224 |
| Device Name: | Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURES |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | CONMED CORPORATION 11311 CONCEPT BLVD. Largo, FL 33773 |
| Contact | Nyrobia Freeman |
| Correspondent | Nyrobia Freeman CONMED CORPORATION 11311 CONCEPT BLVD. 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 | 2013-10-21 |
| Decision Date | 2014-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854606114 | K133224 | 000 |
| 30845854045156 | K133224 | 000 |
| 10845854045152 | K133224 | 000 |
| 10845854045084 | K133224 | 000 |
| 20845854648916 | K133224 | 000 |
| 20845854648923 | K133224 | 000 |
| 20845854648930 | K133224 | 000 |
| 20845854648947 | K133224 | 000 |
| 20845854648954 | K133224 | 000 |
| 20845854648961 | K133224 | 000 |
| 20845854040734 | K133224 | 000 |
| 20845854040741 | K133224 | 000 |
| 20845854080549 | K133224 | 000 |
| 20845854080556 | K133224 | 000 |
| 20845854606107 | K133224 | 000 |
| 30845854045088 | K133224 | 000 |