The following data is part of a premarket notification filed by Newclip Technics with the FDA for Footmotion Plating System.
| Device ID | K161448 |
| 510k Number | K161448 |
| Device Name: | Footmotion Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | NEWCLIP TECHNICS PA De La Lande Saint Martin-45 Rue Des Garottieres Haute-goulaine, FR 44 115 |
| Contact | Gaelle Lussori |
| Correspondent | J. D. Webb THE ORTHOMEDIX GROUP, INC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-25 |
| Decision Date | 2016-10-31 |
| Summary: | summary |