The following data is part of a premarket notification filed by Conmed Linvatec with the FDA for Y-knot All-suture Anchor Model Hf13.
| Device ID | K111779 |
| 510k Number | K111779 |
| Device Name: | Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Contact | John Cusack |
| Correspondent | John Cusack CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-24 |
| Decision Date | 2011-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854606084 | K111779 | 000 |
| 40845854649047 | K111779 | 000 |
| 20845854042004 | K111779 | 000 |
| 20845854649012 | K111779 | 000 |
| 30845854649033 | K111779 | 000 |
| 30845854649040 | K111779 | 000 |
| 20845854649029 | K111779 | 000 |
| 20845854901196 | K111779 | 000 |
| 20845854021658 | K111779 | 000 |
| 20845854029685 | K111779 | 000 |
| 20845854606077 | K111779 | 000 |
| 40845854649030 | K111779 | 000 |