The following data is part of a premarket notification filed by Cable Fix Medical Llc with the FDA for Impress Sfs System.
| Device ID | K173910 |
| 510k Number | K173910 |
| Device Name: | Impress SFS System |
| Classification | Cerclage, Fixation |
| Applicant | Cable Fix Medical LLC 1050 Getwell Road S Hernando, MS 38632 |
| Contact | Carey Bryant |
| Correspondent | Janet Akil M Squared Associates, Inc 575 Eighth Avenue, Suite 1212 New York, NY 10018 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-22 |
| Decision Date | 2018-09-14 |
| Summary: | summary |