Signus Medizintechnik GmbH
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 24
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243188 | CYLOX® ST | February 11, 2025 |
| K241438 | Signus Tetris St; Signus Tetris R St | September 11, 2024 |
| K220658 | COSY Cervicothoracic Occipital Rod-Screw System | November 18, 2022 |
| K212755 | SIGNUS SACRONAIL® Transsacral Stabilization System | March 10, 2022 |
| K203327 | VERTACONNECT TLIF Cage | January 25, 2021 |
| K151704 | Diplomat® Spinal System | April 13, 2016 |
| K141405 | MOBIS II ST SPINAL IMPLANT | September 16, 2014 |
| K123758 | TASMIN R | January 14, 2014 |
| K131372 | MOBIS II | July 2, 2013 |
| K122317 | TETRIS II | August 29, 2012 |
| K111792 | MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI | March 5, 2012 |
| K090387 | KAINOS+ | September 28, 2009 |
| K082848 | NUBIC AND RABEA DEVICES | July 24, 2009 |
| K081332 | ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM | June 10, 2008 |
| K080815 | TOSCA II ANTERIOR CERVICAL PLATE SYSTEM | April 23, 2008 |
| K080349 | KIMBA MINI | March 10, 2008 |
| K061082 | MOBIS SPINAL IMPLANT | December 18, 2006 |
| K061577 | OVALTWIST PEDICLE SCREW SYSTEM | September 14, 2006 |
| K052533 | KIMBA SPINAL IMPLANT | November 3, 2005 |
| K051659 | SEMIAL SPINAL IMPLANT | July 13, 2005 |