Data / Medical devices / Germany / Silony Medical GMBH
Silony Medical GMBH: FDA-registered device maker in Leinfelden-Echterdingen Baden-Wurttemberg, Germany, 26 510(k) clearances
Silony Medical GMBH is registered with the FDA (registration 3013422236) in Leinfelden-Echterdingen Baden-Wurttemberg, Germany. It lists 20 device types. The FDA files 26 510(k) clearances under its listings, the newest dated June 26, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013422236
- Address
- Leinfelder Strasse 60, Leinfelden-Echterdingen Baden-Wurttemberg, Germany, 70771
- Owner or operator
- Silony Medical GmbH (10054311)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- March 7, 2017
- Registered through
- 2026
- Brand names listed
- (Re-)Positioning Tools, Adapter, Awl(s), CERVICAL CAGE, Control Gauges, Counter Torque, Dilatator, Distractor and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 26, 2026 | K253921 | VERTICALE® Navigation Instruments | OLO | Substantially Equivalent | Silony Medical GmbH | accessdata.fda.gov |
| February 19, 2026 | K254148 | VERTICALE GPS Instruments | OLO | Substantially Equivalent | Silony Medical GmbH | accessdata.fda.gov |
| December 22, 2022 | K223649 | VERTICALE® Navigation Instruments | OLO | Substantially Equivalent | Silony Medical GmbH | accessdata.fda.gov |
| August 12, 2021 | K212007 | VERTICALE Navigation Instruments | OLO | Substantially Equivalent | Silony Medical GmbH | accessdata.fda.gov |
| April 7, 2020 | K192013 | VERTICALE® Cervical System | NKG | Substantially Equivalent | Silony Medical GmbH | accessdata.fda.gov |
| July 18, 2019 | K190680 | FAVO S-TLIF | MAX | Substantially Equivalent | Silony Medical GmbH | accessdata.fda.gov |
| June 13, 2019 | K182608 | Oyster ACIF Cage | ODP | Substantially Equivalent | Silony Medical GmbH | accessdata.fda.gov |
| December 13, 2018 | K181899 | ROCCIA® PLIF | MAX | Substantially Equivalent | Silony Medical GmbH | accessdata.fda.gov |
| July 11, 2018 | K180963 | ROCCIA ALIF, ROCCIA TLIF | MAX | Substantially Equivalent | Silony Medical GmbH | accessdata.fda.gov |
| May 8, 2018 | K173347 | STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX | MAX | Substantially Equivalent | Centinel Spine, Inc. | accessdata.fda.gov |
| January 10, 2018 | K171421 | VERTICALE® Posterior Spinal Fixation System/VERTICALE® System | NKB | Substantially Equivalent | Silony Medical GmbH | accessdata.fda.gov |
| December 21, 2017 | K171434 | ROCCIA® MultiLIF | MAX | Substantially Equivalent | Silony Medical GmbH | accessdata.fda.gov |
| June 8, 2017 | K171112 | Trifore(tm) Cervical Plating System | KWQ | Substantially Equivalent | Neurostructures, Inc. | accessdata.fda.gov |
| January 26, 2017 | K162587 | ROCCIA® ACIF | ODP | Substantially Equivalent | Silony Medical GmbH | accessdata.fda.gov |
| December 1, 2015 | K152211 | PCT System | NKG | Substantially Equivalent | Centinel Spine, Inc. | accessdata.fda.gov |
| June 24, 2015 | K150053 | STALIF C; STALIF C-Ti | OVE | Substantially Equivalent | Centinel Spine, Inc. | accessdata.fda.gov |
| June 8, 2015 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | OVD | Substantially Equivalent | Centinel Spine, Inc. | accessdata.fda.gov |
| November 7, 2014 | K141942 | MIDLINE II TI | OVD | Substantially Equivalent | Centinel Spine, Inc. | accessdata.fda.gov |
| October 24, 2014 | K142079 | STALIF CTI, STALIF C | OVE | Substantially Equivalent | Centinel Spine, Inc. | accessdata.fda.gov |
| May 8, 2014 | K133200 | STALIF C(R) | OVE | Substantially Equivalent | Centinel Spine, Inc. | accessdata.fda.gov |
| January 9, 2014 | K133286 | MIDLINE (TM) | OVD | Substantially Equivalent | Centinel Spine, Inc. | accessdata.fda.gov |
| August 28, 2013 | K130461 | STALIF X | OVD | Substantially Equivalent | Centinel Spine, Inc. | accessdata.fda.gov |
| August 31, 2012 | K120819 | STALIF C | OVE | Substantially Equivalent | Centinel Spine, Inc. | accessdata.fda.gov |
| August 30, 2012 | K122444 | CERVICAL CAGE | ODP | Substantially Equivalent | Eisertech, LLC | accessdata.fda.gov |
| July 22, 2011 | K110915 | CERVICAL CAGE | ODP | Substantially Equivalent | Eisertech, LLC | accessdata.fda.gov |
| January 25, 2008 | K072415 | STALIF (TM) C | OVE | Substantially Equivalent | Surgicraft , Ltd. | accessdata.fda.gov |
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Updated June 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.