FDA applicant
Signus Medizintechnik GmbH
FDA records 24 decisions for Signus Medizintechnik GmbH (Chesterland, OH) from 1999 to 2025: 24 510(k) clearances. Most are in product codes MQP (Spinal Vertebral Body Replacement Device) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 163 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 64 predicates, 12 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Signus Medizintechnik”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Signus Medizintechnik GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Signus Medizintechnik GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Signus”
FDA records each applicant name separately; these may or may not be the same firm.