Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615021

FEI Number

1000615957

Entity Name

SIGNUS MEDIZINTECHNIK GMBH

City/State/Country

ALZENAU Bavaria, DE

Establishment Address

Industriestrasse 2, ALZENAU Bavaria D-63755, DE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

SIGNUS Medizintechnik GmbH (Owner Number: 9034279)

Owner / Operator Contact Address

Industriestrasse 2, ALZENAU, DE-NOTA D-63755, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K081332

PMA Number

N/A

All Registered 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+

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2009-08-07
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2009-08-07
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2007-12-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2014-01-16
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-01-16
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2004-03-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-14
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-14
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-14
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-01-14
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2022-11-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-11-24
HWT	Template	Orthopedic	Class 1	888.4800	2016-12-06
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2008-11-11
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2008-11-11
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2008-11-11
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2008-11-11
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-02-03
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-06-02
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-06-02
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-06-02
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2008-11-11
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-10-30
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-12-03
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2004-02-13
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2025-08-19
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-08-19
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-08-19
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-01-14
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-01-14
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-01-17
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2014-01-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2007-04-27
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2007-12-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-01-14
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-01-14
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2009-10-12
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2008-11-11

Official Correspondent

Susanne Siedler

US Agent Details

German American Chamber of Commerce, Inc. German American Ch Email: legalservices@gaccny.com Phone: (212) 9748830

Related Public Records

Same Entity

SIGNUS Medizintechnik GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K041888	Signus Medizintechnik GmbH	CURVED PEEK TETRIS SPINAL IMPLANT	2004-08-10
K211892	Arftx Medical, LLC	ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)	2022-10-06
K070082	Vertebration,Inc	XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY	2007-04-20
K051027	Surgicraft , Ltd.	STALIF TT	2005-06-29
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013	Medtronic Sofamor Danek USA Inc	2	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05	Zimmer Spine, Inc.	2	ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615021. Last updated year: 2026. Please use registration number 9615021 when referencing this establishment in official correspondence.