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Data / Medical devices / Germany / Silony Medical International AG

Silony Medical International AG: FDA-registered device maker in Leinfelden Echterdingen Baden-Wurttemberg, Germany, 26 510(k) clearances

Silony Medical International AG is registered with the FDA (registration 3012764194) in Leinfelden Echterdingen Baden-Wurttemberg, Germany. It lists 21 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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Get makers like this oneWatch Silony Medical International AG
FDA registration number
3012764194
Address
Leinfelder Strasse 60, Leinfelden Echterdingen Baden-Wurttemberg, Germany, 70771
Owner or operator
Silony Medical GmbH (10054311)
Roles
Exporter to the US
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

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Exporter to the USaccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Exporter to the USaccessdata.fda.gov
AwlHWJ1Exporter to the USaccessdata.fda.gov
Chisel, Surgical, ManualFZO1Exporter to the USaccessdata.fda.gov
Dispenser, CementKIH1Exporter to the USaccessdata.fda.gov
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentKIJ1Exporter to the USaccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Exporter to the USaccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Exporter to the USaccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, ThoracicPHM2Exporter to the USaccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Exporter to the USaccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Exporter to the USaccessdata.fda.gov
MalletHXL1Exporter to the USaccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Exporter to the USaccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Exporter to the USaccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Exporter to the USaccessdata.fda.gov
ProbeHXB1Exporter to the USaccessdata.fda.gov
ScrewdriverHXX1Exporter to the USaccessdata.fda.gov
Spinal Channeling Instrument, VertebroplastyOCJ1Exporter to the USaccessdata.fda.gov
Tap, BoneHWX1Exporter to the USaccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Exporter to the USaccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Exporter to the USaccessdata.fda.gov

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 26, 2026K253921VERTICALE® Navigation InstrumentsOLOSubstantially EquivalentSilony Medical GmbHaccessdata.fda.gov
February 19, 2026K254148VERTICALE GPS InstrumentsOLOSubstantially EquivalentSilony Medical GmbHaccessdata.fda.gov
December 22, 2022K223649VERTICALE® Navigation InstrumentsOLOSubstantially EquivalentSilony Medical GmbHaccessdata.fda.gov
August 12, 2021K212007VERTICALE Navigation InstrumentsOLOSubstantially EquivalentSilony Medical GmbHaccessdata.fda.gov
April 7, 2020K192013VERTICALE® Cervical SystemNKGSubstantially EquivalentSilony Medical GmbHaccessdata.fda.gov
July 18, 2019K190680FAVO S-TLIFMAXSubstantially EquivalentSilony Medical GmbHaccessdata.fda.gov
June 13, 2019K182608Oyster ACIF CageODPSubstantially EquivalentSilony Medical GmbHaccessdata.fda.gov
December 13, 2018K181899ROCCIA® PLIFMAXSubstantially EquivalentSilony Medical GmbHaccessdata.fda.gov
July 11, 2018K180963ROCCIA ALIF, ROCCIA TLIFMAXSubstantially EquivalentSilony Medical GmbHaccessdata.fda.gov
May 8, 2018K173347STALIF 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 FLXMAXSubstantially EquivalentCentinel Spine, Inc.accessdata.fda.gov
January 10, 2018K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemNKBSubstantially EquivalentSilony Medical GmbHaccessdata.fda.gov
December 21, 2017K171434ROCCIA® MultiLIFMAXSubstantially EquivalentSilony Medical GmbHaccessdata.fda.gov
June 8, 2017K171112Trifore(tm) Cervical Plating SystemKWQSubstantially EquivalentNeurostructures, Inc.accessdata.fda.gov
January 26, 2017K162587ROCCIA® ACIFODPSubstantially EquivalentSilony Medical GmbHaccessdata.fda.gov
December 1, 2015K152211PCT SystemNKGSubstantially EquivalentCentinel Spine, Inc.accessdata.fda.gov
June 24, 2015K150053STALIF C; STALIF C-TiOVESubstantially EquivalentCentinel Spine, Inc.accessdata.fda.gov
June 8, 2015K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiOVDSubstantially EquivalentCentinel Spine, Inc.accessdata.fda.gov
November 7, 2014K141942MIDLINE II TIOVDSubstantially EquivalentCentinel Spine, Inc.accessdata.fda.gov
October 24, 2014K142079STALIF CTI, STALIF COVESubstantially EquivalentCentinel Spine, Inc.accessdata.fda.gov
May 8, 2014K133200STALIF C(R)OVESubstantially EquivalentCentinel Spine, Inc.accessdata.fda.gov
January 9, 2014K133286MIDLINE (TM)OVDSubstantially EquivalentCentinel Spine, Inc.accessdata.fda.gov
August 28, 2013K130461STALIF XOVDSubstantially EquivalentCentinel Spine, Inc.accessdata.fda.gov
August 31, 2012K120819STALIF COVESubstantially EquivalentCentinel Spine, Inc.accessdata.fda.gov
August 30, 2012K122444CERVICAL CAGEODPSubstantially EquivalentEisertech, LLCaccessdata.fda.gov
July 22, 2011K110915CERVICAL CAGEODPSubstantially EquivalentEisertech, LLCaccessdata.fda.gov
January 25, 2008K072415STALIF (TM) COVESubstantially EquivalentSurgicraft , Ltd.accessdata.fda.gov

Compare with other makers

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.