FDA Registration
Active
🇩🇪 Germany
SIGNUS MEDIZINTECHNIK GMBH
Reg #: 9615021
·
FEI: 1000615957
·
Expires 2026
Products
20
Proprietary Names
33
Establishment Types
4
Classifications
20
Registration Details
- Registration Name
- SIGNUS MEDIZINTECHNIK GMBH
- Registration Number
- 9615021
- FEI Number
- 1000615957
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Industriestrasse 2
- City
- ALZENAU Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K082848
Owner / Operator
- Firm Name
- SIGNUS Medizintechnik GmbH
- Operator Number
- 9034279
- Address
- Industriestrasse 2
- City
- ALZENAU
- State
- DE-NOTA
- Postal Code
- D-63755
- Country
- DE
- Correspondent
- Susanne Siedler
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2009-08-07 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2009-08-07 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2014-01-16 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2014-01-16 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2004-03-19 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-01-14 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-01-14 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-01-14 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-01-14 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2022-11-24 |
| Template | HWT | Class 1 | Orthopedic | No | 2016-12-06 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2004-02-13 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2025-08-19 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2009-10-12 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 1998-07-01 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2016-12-06 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 1998-06-29 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2002-01-08 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2022-03-15 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-03-15 |
Proprietary Names
RABEA SPINAL IMPLANT SYSTEM
NUBIC SPINAL IMPLANT SYSTEM
TOSCA Connector Screw
NUBIC XL SPINAL IMPLANT SYSTEM
NUBIC PEEK
ASCOT spinal implant system
MOBIS II spinal implant system (PEEK variant)
Forceps
MONOPOLY VC PEDICLE SCREW SYSTEM
COSY
template
VERTACONNECT
DIPLOMAT® Spinal System
MOBIS II ST SPINAL IMPLANT SYSTEM
Scissors
CYLOX ST
TETRIS SPINAL IMPLANT SYSTEM
MOBIS SPINAL IMPLANT SYSTEM
KIMBA SPINAL IMPLANT SYSTEM
SEMIAL SPINAL IMPLANT SYSTEM
NOVAL SPINAL IMPLANT SYSTEM
KIMBA mini SPINAL IMPLANT SYSTEM
MOBIS XL SPINAL IMPLANT SYSTEM
TASMIN R spinal implant system
TOSCA ANTERIOR CER
TOSCA SPINAL IMPLANT SYSTEM
RABEA PEEK
TETRIS II SPINAL IMPLANT SYSTEM
KAINOS+
GIBRALT
Microsurgical Instruments
SACRONAIL
DIANA SPINAL IMPLANT SYSTEM
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device