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 |