Signus Medizintechnik GmbH: FDA clearances and approvals
Signus Medizintechnik GmbH has 24 FDA 510(k) clearances (first 1999, latest 2025), across 11 product codes in 1 review panel. Median 510(k) review time: 105 days. Since 2017 its median was 134 days, against 90 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 140 |
| 2013 | 1 | 50 |
| 2014 | 2 | 257 |
| 2015 | 0 | — |
| 2016 | 1 | 294 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 74 |
| 2022 | 2 | 224 |
| 2023 | 0 | — |
| 2024 | 1 | 113 |
| 2025 | 1 | 134 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Signus Medizintechnik GmbH's cleared 510(k)s took a median 134 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | 8 | 8 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 6 | 6 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| JDK | Prosthesis, Hip, Cement Restrictor | 1 | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (24)
Most recent Signus Medizintechnik GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243188 | CYLOX® ST | OVE | 2025-02-11 | 134 |
| K241438 | Signus Tetris St; Signus Tetris R St | MAX | 2024-09-11 | 113 |
| K220658 | COSY Cervicothoracic Occipital Rod-Screw System | NKG | 2022-11-18 | 256 |
| K212755 | SIGNUS SACRONAIL® Transsacral Stabilization System | HWC | 2022-03-10 | 191 |
| K203327 | VERTACONNECT TLIF Cage | MAX | 2021-01-25 | 74 |
| K151704 | Diplomat® Spinal System | NKB | 2016-04-13 | 294 |
| K141405 | MOBIS II ST SPINAL IMPLANT | MAX | 2014-09-16 | 111 |
| K123758 | TASMIN R | MQP | 2014-01-14 | 403 |
| K131372 | MOBIS II | MAX | 2013-07-02 | 50 |
| K122317 | TETRIS II | MAX | 2012-08-29 | 28 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Signus Medizintechnik GmbH.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Signus Medizintechnik GmbH have?
Signus Medizintechnik GmbH has 24 FDA 510(k) clearances (first 1999, latest 2025), across 11 product codes in 1 review panel.
How long does FDA take to clear Signus Medizintechnik GmbH's 510(k)s?
The median time from FDA receipt to decision across Signus Medizintechnik GmbH's cleared 510(k)s is 105 days. Since 2017: 134 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does Signus Medizintechnik GmbH make?
Its most frequent FDA product codes are MQP (Spinal Vertebral Body Replacement Device, 8); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 6); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2).
Has Signus Medizintechnik GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching Signus Medizintechnik GmbH. Related entities may recall under other names.
Next steps
- See all 24 Signus Medizintechnik GmbH clearances with predicates and recalls
- Run predicate analysis for product code MQP, Signus Medizintechnik GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.