The following data is part of a premarket notification filed by In2bones Sas with the FDA for Ankle Fusion Plating System.
| Device ID | K173121 |
| 510k Number | K173121 |
| Device Name: | Ankle Fusion Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | In2Bones SAS 28 Chemin Du Petit Bois Ecully, FR 69130 |
| Contact | Morgane Grenier |
| Correspondent | Christine Scifert MRC-X, LLC 6075 Poplar Ave Suite 500 Memphis, TN 38119 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2017-11-28 |
| Summary: | summary |