FDA.reportPublic FDA data

Silony Medical International AG

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30127641943012764194Silony Medical International AG1N2026-01-01Leinfelder Strasse 60 Leinfelden Echterdingen Baden-Wurttemberg DE 70771

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2060631610390165K254148VERTICALE GPS InstrumentsOLO2026-02-19
2060631679071528K253921VERTICALE® Navigation InstrumentsOLO2026-06-26
2060631340525280K223649VERTICALE® Navigation InstrumentsOLO2022-12-22
2060631055742761K212007VERTICALE Navigation InstrumentsOLO2021-08-12
2060631141102727K192013VERTICALE® Cervical SystemNKG2020-04-07
2060631623859448K190680FAVO S-TLIFMAX2019-07-18
2060631414537688K182608Oyster ACIF CageODP2019-06-13
2060631853378996K181899ROCCIA® PLIFMAX2018-12-13
2060631346181732K180963ROCCIA ALIF, ROCCIA TLIFMAX2018-07-11
2060631236504392K173347STALIF 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 FLXMAX2018-05-08
2060631238432912K171434ROCCIA® MultiLIFMAX2017-12-21
2060631566754643K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemNKB2018-01-10
2060632044788692K171112Trifore(tm) Cervical Plating SystemKWQ2017-06-08
2060631688861702K162587ROCCIA® ACIFODP2017-01-26
2060631980222651K152211PCT SystemNKG2015-12-01
2060631238423342K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiOVD2015-06-08
2060631482571663K150053STALIF C; STALIF C-TiOVE2015-06-24
2060631552928214K142079STALIF CTI, STALIF COVE2014-10-24
2060631761582783K141942MIDLINE II TIOVD2014-11-07
2060631887013796K133286MIDLINE (TM)OVD2014-01-09
2060631125730387K133200STALIF C(R)OVE2014-05-08
2060632011108492K130461STALIF XOVD2013-08-28
2060631793718166K122444CERVICAL CAGEODP2012-08-30
2060631347361890K120819STALIF COVE2012-08-31
2060631010287402K110915CERVICAL CAGEODP2011-07-22
2060631392692446K072415STALIF (TM) COVE2008-01-25
2060631262448550
2060631322633598
2060631324218353
2060631608364464
2060631967453541
2060631120155075
2060631160912999
2060631256002793
2060631297477120
2060631374857252
2060631426475217
2060631442262942
2060631473941981
2060631523175206
2060631878455349
2060632016354749
2060632054796406

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX52019-07-18
OVE52015-06-24
OLO42026-06-26
ODP42019-06-13
OVD42015-06-08
NKG22020-04-07
NKB12018-01-10
KWQ12017-06-08