The following data is part of a premarket notification filed by Newclip Technics with the FDA for Footmotion Hammertoe.
Device ID | K172485 |
510k Number | K172485 |
Device Name: | Footmotion HammerToe |
Classification | Pin, Fixation, Smooth |
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 | HTY |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-17 |
Decision Date | 2018-03-02 |
Summary: | summary |