# Signus Medizintechnik GmbH

- Location (FDA's records): Chesterland, OH
- FDA decisions: 24 (1999–2025): 24 510(k) clearances
- Names in FDA's records: Signus Medizintechnik GmbH (23); Signus Medizintechnik (1)
- Product codes: MQP (8), MAX (6), KWQ (2), NKG (1), HWC (1), MQV (1), MNH (1), NKB (1), OVE (1), JDK (1), ODP (1)
- 510(k) review time since 2016: median 163 days, against 107 for FDA's reviews in the same codes and years (1 of 6 faster)
- Predicates its devices cite: 64 (12 its own); citations of its devices by later devices: 51 (12 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Signus Medical, LLC: 5 (https://510kreport.com/company/signus-medical)
- Stryker Spine: 3 (https://510kreport.com/company/stryker-spine)
- Stryker Corp.: 3 (https://510kreport.com/company/stryker)
- Medtronic Sofamor Danek: 3 (https://510kreport.com/company/medtronic-sofamor-danek)
- Exactech, Inc.: 2 (https://510kreport.com/company/exactech)
- Depuy Spine, Inc.: 2 (https://510kreport.com/company/depuy-spine)
- Orthovita, Inc.: 2 (https://510kreport.com/company/orthovita)
- Synthes Spine: 2 (https://510kreport.com/company/synthes-spine)

## Firms that cite its devices most
- Signus Medical, LLC: 3 (https://510kreport.com/company/signus-medical)
- Theken Surgical,Llc: 3 (https://510kreport.com/company/theken-surgical)
- Icotec AG: 3 (https://510kreport.com/company/icotec)
- Aesculap, Inc.: 3 (https://510kreport.com/company/aesculap)
- Backroads Consulting, Inc.: 2 (https://510kreport.com/company/backroads-consulting)
- Sanacor: 2 (https://510kreport.com/company/sanacor)
- Spineart: 1 (https://510kreport.com/company/spineart)
- Silony Medical GmbH: 1 (https://510kreport.com/company/silony-medical)

## Its most-cited devices
- K041888: Curved Peek Tetris Spinal Implant (2004), cited by 11
- K990345: Rabea Device, Model Pxxxxxx (1999), cited by 6
- K043316: Rabea Spinal Implant (2005), cited by 5
- K111792: Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and Mini (2012), cited by 5
- K082848: Nubic and Rabea Devices (2009), cited by 5
- K061577: Ovaltwist Pedicle Screw System (2006), cited by 4

## Recent decisions
- K243188: Cylox® ST (Feb 11, 2025)
- K241438: Signus Tetris™ St; Signus Tetris™ R St (Sep 11, 2024)
- K220658: COSY Cervicothoracic Occipital Rod-Screw System (Nov 18, 2022)
- K212755: SIGNUS SACRONAIL® Transsacral Stabilization System (Mar 10, 2022)
- K203327: VERTACONNECT TLIF Cage (Jan 25, 2021)
- K151704: Diplomat® Spinal System (Apr 13, 2016)
- K141405: Mobis II ST Spinal Implant (Sep 16, 2014)
- K123758: Tasmin R (Jan 14, 2014)

Source page: https://510kreport.com/company/signus-medizintechnik