FDA.reportPublic FDA data

ISIMAC MACHINE CO INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30079252353007925235ISIMAC MACHINE CO INC.1N2020-04-25321 June Ave Blandon PA US 19510

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1505301068802567K950384SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATORLXT1995-05-22
1505301523517601K122455SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEMKTT2013-04-11
1505301632466535K122211SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTSHAW2012-12-17
1505301152058857K090658SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONALKTT2010-03-03
1505301728311475K082650SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONALKTT2008-11-18
1505301897473600K080153SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEMMQN2008-05-14
1505301061316161K043039SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFEKTT2005-01-18
1505301335296670K040258SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFEKTT2004-03-23
1505301148498440K040083SYNTHES EXTERNAL MIDFACE DISTRACTORMQN2004-03-31
1505302054392436K033158SYNTHES REPROCESSED EXTERNAL FIXATION DEVICESKTT2003-11-05
1505301176550162K030390SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFELXT2003-04-01
1505301117346463
1505301197242208
1505301386361022
1505301594982217
1505301650577751
1505301713329208
1505301773394903
1505301819290364
1505301922431654
1505302032142701

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KTT62013-04-11
MQN22008-05-14
LXT22003-04-01
HAW12012-12-17