The following data is part of a premarket notification filed by Kfx Medical with the FDA for Kfx Knotless Fixation System.
| Device ID | K061294 |
| 510k Number | K061294 |
| Device Name: | KFX KNOTLESS FIXATION SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | KFX MEDICAL 5145 AVENIDA ENCINAS, SUITE C Carlsbad, CA 92008 |
| Contact | Malcolm Heaven |
| Correspondent | Malcolm Heaven KFX MEDICAL 5145 AVENIDA ENCINAS, SUITE C Carlsbad, CA 92008 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-09 |
| Decision Date | 2006-07-19 |
| Summary: | summary |