The following data is part of a premarket notification filed by Conextions Medical with the FDA for Conextions Tr Tendon Repair System.
| Device ID | K203855 |
| 510k Number | K203855 |
| Device Name: | CoNextions TR Tendon Repair System |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| 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 | GAQ |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-31 |
| Decision Date | 2022-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10861445000324 | K203855 | 000 |
| 10861445000317 | K203855 | 000 |
| 10861445000300 | K203855 | 000 |