The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Fitmore® Hip Stem.
Device ID | K170072 |
510k Number | K170072 |
Device Name: | Fitmore® Hip Stem |
Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
Applicant | Zimmer GmbH Sulzerallee 8 Winterthur, CH 8404 |
Contact | Thomas Lincoln |
Correspondent | Thomas Lincoln Zimmer GmbH Sulzerallee 8 Winterthur, CH 8404 |
Product Code | KWY |
Subsequent Product Code | JDI |
Subsequent Product Code | KWL |
Subsequent Product Code | KWZ |
Subsequent Product Code | LWJ |
Subsequent Product Code | LZO |
CFR Regulation Number | 888.3390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-01-09 |
Decision Date | 2017-02-07 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FITMORE 97066514 not registered Live/Pending |
Shenzhen Wanlisheng technology co., ltd 2021-10-08 |
FITMORE 97007162 not registered Live/Pending |
Chengdu Yaoyao Erba Technology Co., Ltd. 2021-09-01 |
FITMORE 77265360 3506235 Live/Registered |
Zimmer GmbH 2007-08-27 |