# Silony Medical GmbH

- Location (FDA's records): Leinfelden-Echterdingen, DE
- FDA decisions: 13 (2017–2026): 13 510(k) clearances
- Product codes: MAX (4), OLO (4), NKB (2), ODP (2), NKG (1)
- 510(k) review time since 2016: median 150 days, against 104 for FDA's reviews in the same codes and years (5 of 13 faster)
- Predicates its devices cite: 27 (6 its own); citations of its devices by later devices: 13 (6 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
- Medtronic Sofamor Danek USA, Inc.: 5 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Nu Vasive, Incorporated: 3 (https://510kreport.com/company/nu-vasive)
- Eit Emerging Implant Technologies GmbH: 2 (https://510kreport.com/company/eit-emerging-implant-technologies)
- Aesculap Implant Systems, LLC: 1 (https://510kreport.com/company/aesculap-implant-systems)
- Signus Medizintechnik GmbH: 1 (https://510kreport.com/company/signus-medizintechnik)
- Synthes (USA) Products, LLC: 1 (https://510kreport.com/company/synthes-usa-products)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)

## Firms that cite its devices most
- Icotec AG: 1 (https://510kreport.com/company/icotec)
- Precision Spine, Inc.: 1 (https://510kreport.com/company/precision-spine)
- Met One Technologies, LLC: 1 (https://510kreport.com/company/met-one-technologies)
- Bk Meditech, Co., Ltd.: 1 (https://510kreport.com/company/bk-meditech)
- Evolution Spine: 1 (https://510kreport.com/company/evolution-spine)
- Republic Spine, LLC: 1 (https://510kreport.com/company/republic-spine)
- S.M.A.I.O: 1 (https://510kreport.com/company/smaio)

## Its most-cited devices
- K171421: VERTICALE® Posterior Spinal Fixation System/VERTICALE® System (2018), cited by 4
- K223649: VERTICALE® Navigation Instruments (2022), cited by 3
- K180963: Roccia Alif, Roccia Tlif (2018), cited by 2
- K162587: Roccia® Acif (2017), cited by 1
- K171434: ROCCIA® MultiLIF (2017), cited by 1
- K212007: VERTICALE Navigation Instruments (2021), cited by 1

## Recent decisions
- K253921: VERTICALE® Navigation Instruments (Jun 26, 2026)
- K254148: VERTICALE GPS Instruments (Feb 19, 2026)
- K223806: VERTICALE® Triangular Fixation System (Jul 6, 2023)
- K223649: VERTICALE® Navigation Instruments (Dec 22, 2022)
- K212007: VERTICALE Navigation Instruments (Aug 12, 2021)
- K192013: VERTICALE® Cervical System (Apr 7, 2020)
- K190680: Favo S-Tlif (Jul 18, 2019)
- K182608: Oyster ACIF Cage (Jun 13, 2019)

Source page: https://510kreport.com/company/silony-medical