The following data is part of a premarket notification filed by Newclip Technics with the FDA for Foot And Hand Motion.
| Device ID | K170012 |
| 510k Number | K170012 |
| Device Name: | Foot And Hand Motion |
| Classification | Screw, Fixation, Bone |
| Applicant | NEWCLIP TECHNICS P.A. De La Lande Saint Martin, 45 Rue Des Garottieres Haute-goulaine, FR F-44115 |
| Contact | Celine Chevrier |
| Correspondent | J. D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-03 |
| Decision Date | 2017-04-24 |
| Summary: | summary |