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SILONY MEDICAL GMBH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30134222363013422236SILONY MEDICAL GMBH1N2026-01-01Leinfelder Strasse 60 Leinfelden-Echterdingen Baden-Wurttemberg DE 70771

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2055421610390165K254148VERTICALE GPS InstrumentsOLO2026-02-19
2055421340525280K223649VERTICALE® Navigation InstrumentsOLO2022-12-22
2055421055742761K212007VERTICALE Navigation InstrumentsOLO2021-08-12
2055421141102727K192013VERTICALE® Cervical SystemNKG2020-04-07
2055421623859448K190680FAVO S-TLIFMAX2019-07-18
2055421414537688K182608Oyster ACIF CageODP2019-06-13
2055421853378996K181899ROCCIA® PLIFMAX2018-12-13
2055421346181732K180963ROCCIA ALIF, ROCCIA TLIFMAX2018-07-11
2055421236504392K173347STALIF 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
2055421238432912K171434ROCCIA® MultiLIFMAX2017-12-21
2055421566754643K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemNKB2018-01-10
2055422044788692K171112Trifore(tm) Cervical Plating SystemKWQ2017-06-08
2055421688861702K162587ROCCIA® ACIFODP2017-01-26
2055421980222651K152211PCT SystemNKG2015-12-01
2055421238423342K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiOVD2015-06-08
2055421482571663K150053STALIF C; STALIF C-TiOVE2015-06-24
2055421552928214K142079STALIF CTI, STALIF COVE2014-10-24
2055421761582783K141942MIDLINE II TIOVD2014-11-07
2055421887013796K133286MIDLINE (TM)OVD2014-01-09
2055421125730387K133200STALIF C(R)OVE2014-05-08
2055422011108492K130461STALIF XOVD2013-08-28
2055421793718166K122444CERVICAL CAGEODP2012-08-30
2055421347361890K120819STALIF COVE2012-08-31
2055421010287402K110915CERVICAL CAGEODP2011-07-22
2055421392692446K072415STALIF (TM) COVE2008-01-25
2055421262448550
2055421322633598
2055421324218353
2055421608364464
2055421967453541
2055421120155075
2055421160912999
2055421256002793
2055421297477120
2055421374857252
2055421426475217
2055421473941981
2055421523175206
2055421878455349
2055422016354749
2055422054796406

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX52019-07-18
OVE52015-06-24
ODP42019-06-13
OVD42015-06-08
OLO32026-02-19
NKG22020-04-07
NKB12018-01-10
KWQ12017-06-08

PMN#

GUDID#

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