The following data is part of a premarket notification filed by Signus Medizintechnik Gmbh with the FDA for Diplomat® Spinal System.
Device ID | K151704 |
510k Number | K151704 |
Device Name: | Diplomat® Spinal System |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | SIGNUS Medizintechnik GmbH Industriestr. 2 Alzenau, DE 63755 |
Contact | Jochim Schneider |
Correspondent | Kenneth C Maxwell Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
Product Code | NKB |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-06-24 |
Decision Date | 2016-04-13 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DIPLOMAT 97869695 not registered Live/Pending |
Hefter, Max 2023-04-03 |
DIPLOMAT 97193297 not registered Live/Pending |
Steve Morgan 2021-12-28 |
DIPLOMAT 87506498 5385479 Live/Registered |
Yuan, Quan 2017-06-27 |
DIPLOMAT 87444425 5442048 Live/Registered |
Hearing Help Express, Inc. 2017-05-10 |
DIPLOMAT 86867058 5556153 Live/Registered |
Abu AB 2016-01-06 |
DIPLOMAT 86628403 4894710 Live/Registered |
SIGNUS Medizintechnik GmbH 2015-05-13 |
DIPLOMAT 86619831 4925612 Live/Registered |
magFlags GmbH 2015-05-05 |
DIPLOMAT 86478042 not registered Dead/Abandoned |
Abu Ab 2014-12-11 |
DIPLOMAT 86441128 4759848 Live/Registered |
Hefter, Max 2014-10-31 |
DIPLOMAT 86413904 not registered Dead/Abandoned |
Barberton Consultores e Serviços LDA. 2014-10-03 |
DIPLOMAT 86295075 4802055 Live/Registered |
Alex's Meat Distributors, Corp. 2014-05-29 |
DIPLOMAT 86051281 4510571 Live/Registered |
DipTech Systems, Inc. 2013-08-29 |