FDA.reportPublic FDA data

SIMAGEC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30104622783010462278SIMAGEC1N2026-01-0154 avenue de la Plaine Z.I. ROUSSET CEDEX Bouches-du-Rhone FR 13106

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1625341939378246K991566SOLUSTAPLEJDR1999-08-03
1625341985864511K991477SPIN SNAP-OFF SCREWHWC1999-07-14
1625341020631616K990622BOLD SCREWHWC1999-04-29
1625341231878466K161414Anatomic Total Knee SystemJWH2017-01-19
1625341330638394K161173Avenue® T TLIF CageOVD2016-09-28
1625341202119374K152137FacetBRIDGE SystemMRW2016-01-25
1625341160202092K133363INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEMPEK2014-03-07
1625341556906038K123134EASYSPINE SYSTEMNKB2013-02-01
1625341947476993K121103LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT SNKB2012-08-24
1625341089620631K093914NEWDEAL COMPRESSION PLATESHRS2011-04-14
1625341731201192K093781MODIFIED: NEWDEAL HALLU PLATESHRS2010-01-22
1625341234627930K091788PANTA NAIL (DIA. 10MM), PANTA NAIL XLHSB2009-07-29
1625341242074240K091088LDR SPINE CERVICAL INTERBODY FUSION SYSTEMODP2009-07-14
1625341469100686K083154NEWDEAL HALLU LOCK PLATE SYSTEMHRS2009-07-10
1625341023606372K073375NEWDEAL TIBIAXYS SYSTEMHRS2008-02-21
1625341429646442K071639QWIX POSITIONING SCREWHWC2007-07-09
1625341558763458K070241MODIFICATION TO LAPIDUS PLATEHRS2007-02-08
1625341319075274K070160MODIFICATION TO TTC PLATESHRS2007-02-08
1625341298398811K063820LISFRANC PLATEHRS2007-02-08
1625341651852760K060476LAPIDUS PLATEHRS2006-05-17
1625341966738049K060474LISFRANC PLATEHRS2006-08-03
1625341679413165K060473TTC PLATEHRS2006-05-17
1625341117450225K050882NEWDEAL ANKLE NAILHSB2005-05-27
1625341810866067K050346STABILIZATION SCREWHWC2005-03-17
1625341722637406K041601SURFIX KNEE OSTEOTOMY SYSTEMHRS2004-08-27
1625341188302468K022599NEWDEAL K WIREHTY2002-10-30
1625341579671170K022597K-FIXHTY2002-11-01
1625341927302818K021626HALLU PLATESHRS2002-08-12
1625341512362259K011946THE SPIN SNAP-OFF SCREWHWC2001-08-24
1625341959541845K011262MODIFICATION TO THE BOLD SCREWHWC2001-06-15
1625341235041428
1625341632421986
1625342047841307
1625341017723338
1625341020289715
1625341020418206
1625341047469925
1625341054776304
1625341061296615
1625341079377193
1625341081505057
1625341089620631
1625341094068254
1625341100150458
1625341140577700
1625341165593659
1625341199500985
1625341200229551
1625341207900489
1625341219870968
1625341231564732
1625341233439665
1625341238130036
1625341298398811
1625341320267231
1625341346286189
1625341363800672
1625341385719868
1625341420143493
1625341437802325
1625341465682069
1625341474310259
1625341477923353
1625341493377434
1625341493572030
1625341495633358
1625341508207396
1625341532017015
1625341543134875
1625341595816651
1625341628844457
1625341629835789
1625341638521327
1625341644196546
1625341662376016
1625341673306280
1625341704825011
1625341709148058
1625341724489175
1625341730218330
1625341758606910
1625341766598085
1625341781827464
1625341793896484
1625341798437620
1625341799244894
1625341817020253
1625341847334522
1625341859957173
1625341863370676
1625341873221059
1625341874460955
1625341876718744
1625341877952758
1625341891924949
1625341895049921
1625341898722039
1625341928697977
1625341968346406
1625341969204823
1625341981862226
1625341987738906
1625342011450653
1625342028059746
1625342035181296
1625342041723525
1625342051417006
1625342059239612

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS122011-04-14
HWC62007-07-09
NKB22013-02-01
HSB22009-07-29
HTY22002-11-01
JWH12017-01-19
OVD12016-09-28
MRW12016-01-25
PEK12014-03-07
ODP12009-07-14
JDR11999-08-03