FDA.reportPublic FDA data

OSTEOMED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20277542027754OSTEOMED1Y2026-01-013885 Arapaho Rd ADDISON TX US 75001

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
424861575854470K990944OSTEOMED INTRAORAL DISTRACTION SYSTEMMQN1999-06-16
424862011000738K974785AUTO-DRIVE BONE SCREWHWC1998-03-18
424861039596891K971692OSTEOPOWER SYSTEM AND ACCESSORIESKMW1997-06-27
424861079283267K963394OSTEOMED TRAMJEY1996-11-14
424861464467744K962774OSTEOMED QUICKFIXDZL1997-10-10
424861695971142K961418OSTEOMED MSSDZL1996-10-25
424861734884091K954330SUPER SCREW 3.5 MMHWC1995-12-08
424861786787360K933101THE OSTEOMED B POWER SYSTEM AND ACCESSORIESKIJ1994-11-07
424861660713587K924138OSTEOMED M3 SYSTEM (SBF SYSTEM)JEY1993-02-17
424861752535638K924018M3 LAG SCREW FIXATION SYSTEMHWC1993-04-01
424861110123743K922211OSTEOMED GREAT TOE SYSTEMLZJ1993-11-09
424861950778282K911937OSTEOMED IB DRILLEFB1991-06-10
424861225654813K911936OSTEOMED SBF SYSTEM (SBF)DZL1991-08-21
424861407261378K203479ExtremiLOCK Lateral Ankle Fusion PlatesHRS2021-02-24
424861554080563K202680OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemHWC2020-10-15
424861825628875K202105OsteoMed ExtremiFix Mini & Small System TrayKCT2020-10-29
424861529985905K163303OsteoMed ExtremiFix Mid and Large Screw SystemHWC2017-04-04
424861428547040K162544OsteoMed PINNACLE DriverKMW2017-04-04
424861689606774K162542OsteoMed PINNACLE DriverHBE2017-05-19
424861409356160K161568Bone Solutions Mixing and Delivery SystemFMF2016-09-16
424861891780186K161041OsteoMed ExtremiLOCK Wrist Plating SystemHRS2016-05-19
424861955983171K152145OsteoMed ExtremiLOCK Wrist Plating SystemHRS2015-12-21
424861491001959K151195OsteoMed IMF ScrewDZL2015-09-21
424861985012684K151021OsteoMed Cannulated Screw SystemHWC2015-07-15
424861943169307K143338Argulated Locking PlatesJEY2015-04-01
424861467163027K141550INSTAFIX SHAPE MEMORY FIXATION SYSTEMJDR2014-07-11
424861073124274K140978OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEMJEY2014-12-18
424861299837463K140283OSTEOMED EXTREMIFUSE SYSTEMHWC2014-02-28
424861110987315K133691EXTRIMILOCK ANKLE PLATING SYSTEMHRS2014-02-24
424861853269571K1334371ST MTP PLATEHRS2013-12-02
424861794617569K131851OSTEOMED NEURO RONGEURHAE2013-12-06
424861714058011K131445OSTEOMED EXTREMILOCK FOOT PLATING SYSTEMHRS2013-06-18
424861957542842K130412OSTEOMED EXTREMIFUSE SYSTEMHWC2013-05-31
424861543111558K123885OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTORPBJ2013-06-03
424861157939662K121304OSTEOMED CRANIAL DISTRACTION SYSTEMPBJ2012-08-22
424861805049032K111419OSTEOMED HAND FUSION SYSTEMHRS2011-10-07
424861333949525K111176OSTEOMED LOW PROFILE NEURO FIXATION SYSTEMGWO2011-08-15
424861924530243K100986CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATIONMQV2010-07-20
424861722381804K091614OSTEOMED FOOT PLATING SYSTEMHRS2009-09-10
424861340244383K090522OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEMHRS2009-07-02
424861293719799K081876OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATINGKWD2008-08-01
424861423850133K080694OSTEOMED MODULAR LOCKING FIXATION SYSTEMJEY2008-05-15
424861901746383K071477REVERTO 55 AND 37 SHAPE MEMORY STAPLESJDR2007-08-15
424861689106702K071105OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEMHRS2007-07-30
424861955008071K071004OSTEOCRETE BONE VOID FILLERMQV2009-05-21
424861855509070K063792OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEMMQN2007-03-02
424861467876685K063298OSTEOMED HEADLESS CANNULATED SCREW SYSTEMHWC2007-03-02
424861830715449K062863OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEMHWC2006-10-31
424861177741290K062851OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDEDMQN2006-11-17
424861757688539K060536OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEMKWD2006-06-02
424861518706072K060026KOBY SURGICAL INTERNAL FIXATION SYSTEMHWC2006-01-26
424861228281800K051798OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEMDZE2006-04-07
424861704575330K051784OSTEOVATION CMF BONE VOID FILLERGXP2005-07-20
424861585960803K051123CALLOS IMPACT AND INJECT BONE VOID FILLERMQV2005-06-03
424861513715021K043434OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEMMQN2005-02-10
424861472861863K031936OSTEOMED ORTHODONTIC SCREW SYSTEMDZE2004-01-07
424861218567553K031708OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEMMQN2003-11-03
424861069799202K031701OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEMNEI2004-07-08
424861435405906K031155OSTEOMED SUBTALAR IMPLANT SYSTEMHWC2003-08-22
424861203845381K030448OSTEOMED 2.0 LOCKING PLATES AND SCREWSJEY2003-05-09
424861513369688K0232601.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEMHWC2002-10-18
424861257894229K022887INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMKWH2002-11-26
424861773824672K022886METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMKWH2002-11-25
424861452966514K022277OSTEOMED CRANIAL FLAP FIXATION SYSTEMGXN2003-04-01
424861652181920K021618OSA RIGID INTERNAL FIXATION SYSTEMJEY2002-08-08
424861729120223K013618INTRAORAL MANDIBULAR DISTRACTION SYSTEMMQN2002-08-14
424861401653349K010964AUTO-DRIVE LAG SCREW SYSTEMHWC2001-07-05
424861809241762K0107832.0/2.4 CANNULATED SCREW SYSTEMHWC2001-05-30
424861066711880
424861223771211
424861596008668
424861636674265
424861643505603
424861670905204
424861694016037
424861828129191
424861891097559
424861933092224
424862060506139
424861068786783
424861161534188
424861201435963
424861252337704
424861274156794
424861309699296
424861394939043
424861406020787
424861508468537
424861509279959
424861528444909
424861554354080
424861608753821
424861612386882
424861613703776
424861625584276
424861643237642
424861644166650
424861652642258
424861665367593
424861669985364
424861721175447
424861734391482
424861779649426
424861786965180
424861791895353
424861809738348
424861826458713
424861852884095
424861890060142
424861893048144
424861893836049
424861967447020
424861969834965
424861986640207
424862014628597
424862033585260
424862034056003
424862067811833

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HWC152020-10-15
HRS102021-02-24
JEY72015-04-01
MQN62007-03-02
DZL42015-09-21
MQV32010-07-20
KMW22017-04-04
JDR22014-07-11
PBJ22013-06-03
KWD22008-08-01
DZE22006-04-07
KWH22002-11-26
KCT12020-10-29
HBE12017-05-19
FMF12016-09-16
HAE12013-12-06
GWO12011-08-15
GXP12005-07-20
NEI12004-07-08
GXN12003-04-01
KIJ11994-11-07
LZJ11993-11-09
EFB11991-06-10

PMN#