The following data is part of a premarket notification filed by Kfx Medical with the FDA for Kfx Peek Bone Anchor With Pre-attached Sutures And Inserter Handle.
| Device ID | K083609 |
| 510k Number | K083609 |
| Device Name: | KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | KFX MEDICAL 5845 AVENIDA ENCINAS,SUITE 128 Carlsbad, CA 92008 |
| Contact | Gayle Hirota |
| Correspondent | Gayle Hirota KFX MEDICAL 5845 AVENIDA ENCINAS,SUITE 128 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 | 2008-12-08 |
| Decision Date | 2009-03-06 |
| Summary: | summary |