The following data is part of a premarket notification filed by Kfx Medical with the FDA for Suture Lock Nail Bone Anchor With White (kfx-w-200) & Blue (kfx-b-200) Fiberforce Suture.
| Device ID | K081598 |
| 510k Number | K081598 |
| Device Name: | SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-06 |
| Decision Date | 2008-07-03 |
| Summary: | summary |