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Data / Medical devices / Germany / Signus Medizintechnik GMBH

Signus Medizintechnik GMBH: FDA-registered device maker in ALZENAU Bavaria, Germany, 25 510(k) clearances

Signus Medizintechnik GMBH is registered with the FDA (registration 9615021) in ALZENAU Bavaria, Germany. It lists 20 device types. The FDA files 25 510(k) clearances under its listings, the newest dated July 10, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Signus Medizintechnik GMBH
FDA registration number
9615021
FEI number
1000615957
Address
Industriestrasse 2, ALZENAU Bavaria, Germany, D-63755
Owner or operator
SIGNUS Medizintechnik GmbH (9034279)
Roles
Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
First device listed
June 29, 1998
Registered through
2026
Brand names listed
ASCOT spinal implant system, COSY, CYLOX ST, DIANA SPINAL IMPLANT SYSTEM, DIPLOMAT® Spinal System, Forceps, GIBRALT, KAINOS+ and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Complaint file establishment, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Complaint file establishment, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Filler, Bone Void, Calcium CompoundMQV2Complaint file establishment, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
ForcepsHTD1Complaint file establishment, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Complaint file establishment, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Instrument, MicrosurgicalGZX1Complaint file establishment, Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Complaint file establishment, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Complaint file establishment, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Complaint file establishment, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Nail, Fixation, BoneJDS2Complaint file establishment, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Complaint file establishment, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Complaint file establishment, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Complaint file establishment, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Complaint file establishment, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Complaint file establishment, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Screw, Fixation, BoneHWC2Complaint file establishment, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Complaint file establishment, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
TemplateHWT1Complaint file establishment, Exporter to the US, Specification developeraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Complaint file establishment, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Complaint file establishment, Exporter to the US, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 10, 2026K261031POSEIDON STMQPSubstantially EquivalentSignus Medinzintechnik GmbHaccessdata.fda.gov
February 11, 2025K243188CYLOX® STOVESubstantially EquivalentSignus Medizintechnik GmbHaccessdata.fda.gov
September 11, 2024K241438Signus Tetris™ St; Signus Tetris™ R StMAXSubstantially EquivalentSignus Medizintechnik GmbHaccessdata.fda.gov
November 18, 2022K220658COSY Cervicothoracic Occipital Rod-Screw SystemNKGSubstantially EquivalentSignus Medizintechnik GmbHaccessdata.fda.gov
March 10, 2022K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemHWCSubstantially EquivalentSignus Medizintechnik GmbHaccessdata.fda.gov
January 25, 2021K203327VERTACONNECT TLIF CageMAXSubstantially EquivalentSignus Medizintechnikaccessdata.fda.gov
June 28, 2016K160697Gibralt® Spine System and Gibralt® Occipital Spine SystemNKGSubstantially EquivalentExactech, Inc.accessdata.fda.gov
April 13, 2016K151704Diplomat® Spinal SystemNKBSubstantially EquivalentSignus Medizintechnik GmbHaccessdata.fda.gov
September 16, 2014K141405MOBIS II ST SPINAL IMPLANTMAXSubstantially EquivalentSignus Medizintechnik GmbHaccessdata.fda.gov
January 14, 2014K123758TASMIN RMQPSubstantially EquivalentSignus Medizintechnik GmbHaccessdata.fda.gov
December 23, 2013K132310ASCOTKWQSubstantially EquivalentBackroads Consulting, Inc.accessdata.fda.gov
July 2, 2013K131372MOBIS IIMAXSubstantially EquivalentSignus Medizintechnik GmbHaccessdata.fda.gov
August 29, 2012K122317TETRIS IIMAXSubstantially EquivalentSignus Medizintechnik GmbHaccessdata.fda.gov
March 5, 2012K111792MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINIMAXSubstantially EquivalentSignus Medizintechnik GmbHaccessdata.fda.gov
September 28, 2009K090387KAINOS+MQVSubstantially EquivalentSignus Medizintechnik GmbHaccessdata.fda.gov
September 18, 2009K091122DIANA FUSION CAGEMAXSubstantially EquivalentSignus Medicalaccessdata.fda.gov
August 7, 2009K092073MONOPOLY PEDICLE SCREW SYSTEMNKBSubstantially EquivalentSignus Medicalaccessdata.fda.gov
July 24, 2009K082848NUBIC AND RABEA DEVICESODPSubstantially EquivalentSignus Medizintechnik GmbHaccessdata.fda.gov
July 14, 2008K081108MONOPOLY PEDICLE SCREW SYSTEMNKBSubstantially EquivalentSignus Medical, LLCaccessdata.fda.gov
June 10, 2008K081332ATHLET VERTEBRAL BODY REPLACEMENT SYSTEMMQPSubstantially EquivalentSignus Medizintechnik GmbHaccessdata.fda.gov
April 23, 2008K080815TOSCA II ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially EquivalentSignus Medizintechnik GmbHaccessdata.fda.gov
August 16, 2005K052096NUBIC SPINAL IMPLANTMQPSubstantially EquivalentSignus Medical, LLCaccessdata.fda.gov
February 7, 2005K043316RABEA SPINAL IMPLANTMQPSubstantially EquivalentSignus Medizintechnik GmbHaccessdata.fda.gov
November 23, 2004K043082THE TOSCA ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially EquivalentSignus Medizintechnik GmbHaccessdata.fda.gov
October 22, 2003K031455CONKLUSION PEDICLE SCREW SYSTEMMNISubstantially EquivalentSignus Medical, LLCaccessdata.fda.gov

Compare with other makers

Updated July 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.