FDA.reportPublic FDA data

Aristotech Industries GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30143146233014314623Aristotech Industries GmbH1N2026-01-01Alt-Lankwitz 102 Berlin DE 12447

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2155591804695351K181026OsteoBridge™ IDSF SystemHSB2018-10-17
2155591340028713K172213MECRON Cannulated Screw SystemHWC2017-10-23
2155591337418933K160548MC-Subtalar(TM) IIHWC2016-04-29
2155591593671350K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off ScrewsHWC2016-02-12
2155591921622357K151762PediatrOS RigidTack/FlexTackJDR2015-12-28
2155591707909249K142451OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemHSB2015-02-09
2155591631532124K141377BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARDLZO2014-11-21
2155591048713165K140069LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0HRS2014-04-07
2155591531166742K132226METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHTHRS2013-08-09
2155591465828854K130400MERETEC CS, CORTICAL SCREWSHWC2013-04-05
2155591260517066K123619INTRABLOCK BIOBALL HIP SYSTEM (IBS)LZO2013-05-24
2155591759030992K120978OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLARHSB2012-05-02
2155591228304891K120787MERETE LOCKING BONE PLATE SYSTEM IIIHRS2012-11-27
2155592001313659K113303OSLEOBRIDGE IDSF SPACER CONECTORHSB2011-12-09
2155591723615510K102777TWISTCUT ENDOSORB SCREWSJDW2010-12-20
2155591560018784K102688MERETE LOCKING BONE PLATE SYSTEM IIKTT2010-12-03
2155591283657151K101939OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEMHSB2010-10-07
2155591728794746K100414PROTOE ENDOSORB SMALL HAMMER TOE PINJDW2010-07-02
2155592011721237K091798MERETE COMPRESSION SCREWSHWC2009-09-02
2155591702141133K090063MERETE LOCKING BONE PLATE SYSTEMKTT2009-04-22
2155591030032044K081513MERETE 3.0 AND 3.5 MM LOCKING SCREWSHWC2008-07-18
2155591461531403K072251MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEMLZJ2008-05-08
2155591167464112K063487MERETE BLP SMALL FRAGMENT LOCKING BONE PLATEKTT2007-01-22
2155591281291466K051965OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEMHSB2006-06-16
2155591038915236K051323MERETE TWISTCUT SNAP-OFF BONE SCREWHWC2005-07-07
2155591749535536K050924MERETE DUOTHREADTM BONE SCREWHWC2005-05-27
2155591539526018K050457MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEMKTT2005-03-14
2155591076871797
2155591107457186
2155591161122063
2155591351212749
2155591431839104
2155591548535132
2155591604150063
2155591640940842
2155591703805174
2155591960491609
2155592046424714
2155592073131299
2155591030032044
2155591038915236
2155591228304891
2155591283657151
2155591324357914
2155591340028713
2155591402698680
2155591465828854
2155591539526018
2155591560018784
2155591593671350
2155591620034194
2155591670847436
2155591702141133
2155591759030992
2155591804695351
2155591834232688
2155591864373729
2155591921622357
2155592011721237
2155592019678944
2155592044238635
2155592052660363

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HWC82017-10-23
HSB62018-10-17
KTT42010-12-03
HRS32014-04-07
LZO22014-11-21
JDW22010-12-20
JDR12015-12-28
LZJ12008-05-08