TECRES SPA

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
96148413002808402TECRES SPA1N2026-01-01VIA ANDREA DORIA 6 SOMMACAMPAGNA VERONA Veneto IT 37066

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
547401932844587K252326InterSpace GV Hip SpacerKWL2025-08-06
547401252262637K223709Kyphoplasty Balloon CatheterHRX2023-08-16
547401002062983K220131KYPHON VuE Bone CementNDN2022-04-18
547401555928463K181732InterSpace Knee Extra-Large Size, InterSpace Knee ATSJWH2019-04-27
547401586800778K143134NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV SystemLOD2015-03-05
547401631618481K143100NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System GentaLOD2015-03-05
547401537861935K122175MENDEC SPINE HV, MENDEC SPINE HV SYSTEMNDN2013-03-28
547401892755726K112983SPACER-SHSD2011-12-12
547401059928574K101356Spacer-G and Spacer-KKWL2011-09-20
547401925710742K092773CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FASTLOD2009-11-24
547401555108979K062452KIT MENDEC SPINE AND DELIVERY SYSTEMNDN2006-09-21
547401392304881K053189COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIESJDC2005-12-09
547401162793550K042415MENDEC SPINENDN2005-06-09
547401352849673K031430CEMEX SYSTEM FASTLOD2003-05-22
547401093705987K021765CEMENT RESTRICTOR, SMALL AND LARGEJDK2002-08-16
547401993030934K021715CEMEX RX, CEMEX ISOPLASTIC & CEMEX XLLOD2002-06-12
547401238257084K000943CEMEX SYSTEM GUN APPLICATION VERSIONLOD2001-02-08
547401238257084K000943CEMEX SYSTEM GUN APPLICATION VERSIONLOD2001-02-08
5474010086556001969-12-31
5474010086556001969-12-31
5474010086556001969-12-31
5474010086556001969-12-31
5474011840954981969-12-31
5474011840954981969-12-31
5474011840954981969-12-31
5474011840954981969-12-31
5474012558852111969-12-31
5474012558852111969-12-31
5474012558852111969-12-31
5474012558852111969-12-31
5474016987268651969-12-31
5474016987268651969-12-31
5474016987268651969-12-31
5474016987268651969-12-31
547401008655600
547401041139214
547401072066950
547401116336343
547401178203209
547401183199514
547401260748699
547401440121337
547401476317933
547401511843316
547401516547943
547401650540195
547401704027841
547401717810141
547401762848037
547401816101735
547401816381531
547401868962470
547401892076979
547401995825329
547401996940278
547402017306400

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
LOD72015-03-05
NDN42022-04-18
KWL22025-08-06
HRX12023-08-16
JWH12019-04-27
HSD12011-12-12
JDC12005-12-09
JDK12002-08-16

PMA

PMN

Applications

GUDID

2Mix

2024-02-12

TECRES SPA