Total clearances
5
2021-01-25 → 2025-02-11
Name variants in FDA filings: Signus Medizintechnik / Signus Medizintechnik GmbH
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| MAX |
Intervertebral Fusion Device With Bone Graft, Lumbar |
Class II |
Orthopedic |
2 |
2024-09-11 |
| OVE |
Intervertebral Fusion Device With Integrated Fixation, Cervical |
Class II |
Orthopedic |
1 |
2025-02-11 |
| NKG |
Posterior Cervical Screw System |
Class II |
Orthopedic |
1 |
2022-11-18 |
| HWC |
Screw, Fixation, Bone |
Class II |
Orthopedic |
1 |
2022-03-10 |
Filings
All 510(k) clearances (5)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2025-02-11 |
K243188 |
CYLOX® ST |
OVE |
Class II |
Orthopedic |
| 2024-09-11 |
K241438 |
Signus Tetris St; Signus Tetris R St |
MAX |
Class II |
Orthopedic |
| 2022-11-18 |
K220658 |
COSY Cervicothoracic Occipital Rod-Screw System |
NKG |
Class II |
Orthopedic |
| 2022-03-10 |
K212755 |
SIGNUS SACRONAIL® Transsacral Stabilization System |
HWC |
Class II |
Orthopedic |
| 2021-01-25 |
K203327 |
VERTACONNECT TLIF Cage |
MAX |
Class II |
Orthopedic |