Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Signus Medizintechnik GmbH · Predicate Candidate Screening

23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

111 daysmedian FDA review time
294 days90th percentile
23clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243188CYLOX® STSignus Medizintechnik GmbH2025-02-111340
K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH2024-09-111130
K220658COSY Cervicothoracic Occipital Rod-Screw SystemSignus Medizintechnik GmbH2022-11-182560
K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH2022-03-101910
K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH2016-04-132940
K141405MOBIS II ST SPINAL IMPLANTSignus Medizintechnik GmbH2014-09-161110
K123758TASMIN RSignus Medizintechnik GmbH2014-01-144030
K131372MOBIS IISignus Medizintechnik GmbH2013-07-02500
K122317TETRIS IISignus Medizintechnik GmbH2012-08-29280
K111792MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MSignus Medizintechnik GmbH2012-03-052520
K090387KAINOS+Signus Medizintechnik GmbH2009-09-282230
K082848NUBIC AND RABEA DEVICESSignus Medizintechnik GmbH2009-07-242980
K081332ATHLET VERTEBRAL BODY REPLACEMENT SYSTEMSignus Medizintechnik GmbH2008-06-10290
K080815TOSCA II ANTERIOR CERVICAL PLATE SYSTEMSignus Medizintechnik GmbH2008-04-23300
K080349KIMBA MINISignus Medizintechnik GmbH2008-03-10280
K061082MOBIS SPINAL IMPLANTSignus Medizintechnik GmbH2006-12-182440
K061577OVALTWIST PEDICLE SCREW SYSTEMSignus Medizintechnik GmbH2006-09-14990
K052533KIMBA SPINAL IMPLANTSignus Medizintechnik GmbH2005-11-03490
K051659SEMIAL SPINAL IMPLANTSignus Medizintechnik GmbH2005-07-13210
K043316RABEA SPINAL IMPLANTSignus Medizintechnik GmbH2005-02-07670
K043082THE TOSCA ANTERIOR CERVICAL PLATE SYSTEMSignus Medizintechnik GmbH2004-11-23150
K041888CURVED PEEK TETRIS SPINAL IMPLANTSignus Medizintechnik GmbH2004-08-10290
K990345RABEA DEVICE, MODEL PXXXXXXSignus Medizintechnik GmbH1999-07-301760

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda