The following data is part of a premarket notification filed by Conextions Medical with the FDA for Coronet Soft Tissue Fixation System.
| Device ID | K200028 |
| 510k Number | K200028 |
| Device Name: | Coronet Soft Tissue Fixation System |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | CoNextions Medical 150 North Wright Brothers Drive Suite 560 Salt Lake City, UT 84116 |
| Contact | Matthew Swift |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, PA 19103 |
| Product Code | MBI |
| Subsequent Product Code | HTN |
| Subsequent Product Code | HWC |
| Subsequent Product Code | JDR |
| Subsequent Product Code | KGS |
| Subsequent Product Code | MAI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-06 |
| Decision Date | 2020-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10861445000331 | K200028 | 000 |