510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Signus Medizintechnik GmbH

ALZENAU Bavaria, DE

SIGNUS MEDIZINTECHNIK GMBH appears in FDA device records in ALZENAU Bavaria, DE. FDA records list 24 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
24
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 24 510(k) clearances for Signus Medizintechnik GmbH between 1999 and 2025. The busiest year on record is 2005, with 3. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Signus Medizintechnik GmbH, by decision year
YearClearances
19991
20042
20053
20062
20083
20092
20122
20131
20142
20161
20211
20222
20241
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243188CYLOX® STOVESubstantially Equivalent
K241438Signus Tetris™ St; Signus Tetris™ R StMAXSubstantially Equivalent
K220658COSY Cervicothoracic Occipital Rod-Screw SystemNKGSubstantially Equivalent
K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemHWCSubstantially Equivalent
K203327VERTACONNECT TLIF CageMAXSubstantially Equivalent
K151704Diplomat® Spinal SystemNKBSubstantially Equivalent
K141405MOBIS II ST SPINAL IMPLANTMAXSubstantially Equivalent
K123758TASMIN RMQPSubstantially Equivalent
K131372MOBIS IIMAXSubstantially Equivalent
K122317TETRIS IIMAXSubstantially Equivalent
K111792MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINIMAXSubstantially Equivalent
K090387KAINOS+MQVSubstantially Equivalent
K082848NUBIC AND RABEA DEVICESODPSubstantially Equivalent
K081332ATHLET VERTEBRAL BODY REPLACEMENT SYSTEMMQPSubstantially Equivalent
K080815TOSCA II ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially Equivalent
K080349KIMBA MINIMQPSubstantially Equivalent
K061082MOBIS SPINAL IMPLANTMQPSubstantially Equivalent
K061577OVALTWIST PEDICLE SCREW SYSTEMMNHSubstantially Equivalent
K052533KIMBA SPINAL IMPLANTMQPSubstantially Equivalent
K051659SEMIAL SPINAL IMPLANTMQPSubstantially Equivalent
K043316RABEA SPINAL IMPLANTMQPSubstantially Equivalent
K043082THE TOSCA ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially Equivalent
K041888CURVED PEEK TETRIS SPINAL IMPLANTMQPSubstantially Equivalent
K990345RABEA DEVICE, MODEL PXXXXXXJDKUnknown

Registered establishments

FDA registered establishments for Signus Medizintechnik GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96150211000615957SIGNUS MEDIZINTECHNIK GMBHIndustriestrasse 2, ALZENAU Bavaria D-63755 DE2026and 10 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain