FDA.reportPublic FDA data

KLS-Martin L.P.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10579461000525271KLS-Martin L.P.1Y2026-01-0111201 Saint Johns Industrial Pkwy S Jacksonville FL US 32246

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00888118108357DISTRACTION, INTERNAL, STERILE - SIZER, FOR 51-556-15-71 AND 51-556-20-71, POLYAMIDE+1(904)641-7746KLS-UDI-Info@klsmartin.com
00888118108364DISTRACTION, INTERNAL, STERILE - SIZER, FOR 51-557-15-71 AND 51-557-20-71, POLYAMIDE+1(904)641-7746KLS-UDI-Info@klsmartin.com
00888118147226LEVEL ONE EXTREMITY - BLOCK, DRILL GUIDE, IXOS, P4 WAVE, WIDE, LEFT+1(904)641-7746KLS-UDI-Info@klsmartin.com
00888118147233LEVEL ONE EXTREMITY - BLOCK, DRILL GUIDE, IXOS, P4 WAVE, WIDE, RIGHT+1(904)641-7746KLS-UDI-Info@klsmartin.com
00888118147240LEVEL ONE EXTREMITY - BLOCK, DRILL GUIDE, IXOS, P6, MEDIUM, LEFT+1(904)641-7746KLS-UDI-Info@klsmartin.com
00888118147257LEVEL ONE EXTREMITY - BLOCK, DRILL GUIDE, IXOS, P6, MEDIUM, RIGHT+1(904)641-7746KLS-UDI-Info@klsmartin.com
00888118147264LEVEL ONE EXTREMITY - BLOCK, DRILL GUIDE, IXOS, P6, WIDE, LEFT+1(904)641-7746KLS-UDI-Info@klsmartin.com
00888118147271LEVEL ONE EXTREMITY - BLOCK, DRILL GUIDE, IXOS, P6, WIDE, RIGHT+1(904)641-7746KLS-UDI-Info@klsmartin.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3216441520352829K994154MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIESJEY2000-02-15
3216441430557983K990667KLS-MARTIN TEMPORARY CONDYLAR IMPLANTNEI2001-07-27
3216441132233490K983809KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTORMQN1999-01-26
3216441195811518K980760KLS-MARTIN MMF SCREWDZL1999-12-21
3216441578436946K972047KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICEMQN1997-06-24
3216441964557538K971297CENTRE-DRIVE DRILL-FREE SCREWHRS1997-05-08
3216441374266622K944565KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM)JEY1994-10-18
3216441997075225K944561MICRO OSTEOSYNTHESIS SYSTEM (1.0)JEY1994-10-18
3216441364425827K943348KLS CHIN PLATE SYSTEMJEY1994-10-04
3216441242986598K943347KLS MINI OSTEOSYNTHESIS SYSTEMJEY1994-10-04
3216441669663593K254162KLS Martin Ixos SystemHRS2026-02-20
3216442060849604K253660KLS Martin Pure Pectus SystemHRS2026-02-20
3216441081073352K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILEGXN2025-11-10
3216441367058578K250988KLS Martin Pure Pectus SystemHRS2025-12-11
3216441411046495K250865KLS Martin IPS Forearm SystemHRS2025-11-14
3216441071228833K250620KLS Martin Ixos SystemHRS2025-08-15
3216441429800169K241018KLS Martin Orthopedic Implants - MR ConditionalHRS2024-07-12
3216441628858691K233721KLS Martin Drill-Free MMF ScrewDZL2024-09-17
3216441428246309K230211CranioXpandPBJ2023-11-21
3216441997791043K222624KLS Martin LINOS Wrist SystemHRS2023-05-25
3216441454895887K222397KLS Martin Level One Rib Fixation SystemHRS2023-03-29
3216441781325043K221938KLS Martin Pure Pectus SystemHRS2023-03-28
3216441259617054K220050KLS Martin IPS DistractionMQN2022-08-11
3216441280912359K210741KLS Martin Neuro RongeursHAE2022-06-03
3216441137985135K210731KLS Martin Individual Patient SolutionsJEY2022-07-18
3216441308281968K210228KLS Martin IPS PreprostheticELE2022-07-08
3216441778166530K201052KLS Martin Individual Patient Solutions (IPS) Planning SystemPPT2020-08-31
3216441537872368K192979KLS Martin Individual Patient Solutions (IPS) Planning SystemPBF2020-03-11
3216441037743947K191028KLS Martin Individual Patient SolutionsJEY2019-11-22
3216441641279575K182889KLS Martin Individual Patient Solutions (IPS) Planning SystemPPT2019-07-26
3216441399826931K182789KLS Martin Individual Patient Solutions (IPS) Planning SystemDZJ2019-03-11
3216441857294681K181241KLS Martin Individual Patient Solutions (IPS) Planning SystemDZJ2018-09-13
3216441906968029K180962KLS Martin Individual Patient SolutionsJEY2018-08-13
3216441413055480K173320KLS Martin L1 MMF SystemJEY2018-02-23
3216441972722177K170124Level One Hand Plating SystemHRS2017-03-09
3216442024406918K163579KLS Martin Individual Patient SolutionsJEY2017-11-21
3216441296358460K163315Internal Distraction - SterilePBJ2017-05-05
3216441169742175K161470Internal Distraction - SterileMQN2016-12-01
3216441939876838K161259KLS Martin Cannulated Headless ScrewsHWC2016-12-19
3216441252639001K153482KLS Martin Thoracic Plating SystemHRS2016-04-06
3216441899417699K151983KLS Martin LSS Plating SystemJDQ2016-04-06
3216441397439550K151382Patient Contoured Implant-PEEK (PCI-PEEK)GXN2015-11-09
3216441216565235K141489LINOS MOH HAND PLATING SYSTEMHRS2014-07-24
3216441066275630K133304RXG DISTRACTION SYSTEMJEY2014-05-15
3216441083216510K122860KLS MARTIN RECON TALONHRS2012-11-14
3216441160010995K121606RESORB-X GGWO2013-01-17
3216441212121631K112064RESORB X-GJEY2012-03-23
3216442026186389K083432DRILL FREE MMF SCREWDZL2009-03-31
3216441793995780K080862SONICWELD RX (RESORB-X)JEY2008-07-21
3216441500753125K072764KLS MARTIN XTERNAL FIXATORMQN2007-12-20
3216441974264100K072707PATIENT CONTOURED MESH-PEEK (PCM-P)GXN2007-12-19
3216441835327222K070169KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILEHRS2007-03-26
3216441221802915K062570PATIENT CONTOURED MESH (PCM)GXN2006-10-31
3216441522758036K060177KLS MARTIN RIGID FIXATION - STERILEJEY2006-04-18
3216441281932117K042573KLS MARTIN DRILL-FREE MMF SCREWDZL2004-10-18
3216441465120137K042066KLSA MARTIN HAND DISTRACTORJEC2004-08-25
3216441006145794K040891KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES)DZE2004-05-28
3216441632965136K040598KLS MARTIN HAND PLATING SYSTEMHRS2004-05-13
3216441824782767K034027KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEMMQN2004-02-27
3216441202530249K033483KLS-MARTIN ORTHO ANCHORAGE SYSTEMDZE2004-01-15
3216442044797394K032442KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM IIMQN2003-10-29
3216441514045577K032413KLS-MARTIN STERNAL PLATING SYSTEMHRS2003-10-10
3216441114079381K010139ZURICH DISTRACTION SYSTEMMQN2001-06-29
3216441417968199K002152TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTIONMQN2000-10-10
3216441002888613
3216441007334230
3216441012413796
3216441033759285
3216441034496437
3216441040011334
3216441042183464
3216441043974591
3216441063215024
3216441069687452
3216441080116223
3216441085308345
3216441087874323
3216441090907156
3216441099204718
3216441130563978
3216441150409104
3216441154359015
3216441156543505
3216441158794792
3216441166361159
3216441177437955
3216441186289614
3216441188124931
3216441188140648
3216441189335849
3216441203769054
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3216441206753541
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3216441211106418
3216441226085196
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3216441237171081
3216441261182322
3216441272714059
3216441274108225
3216441277593746
3216441288714048
3216441294442398
3216441295971285
3216441299930531
3216441326098627
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3216441350839432
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3216441388665128
3216441389285040
3216441390632104
3216441405162841
3216441406047860
3216441420027727
3216441435359839
3216441438074744
3216441440202814
3216441450505074

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS172026-02-20
JEY142022-07-18
MQN92022-08-11
GXN42025-11-10
DZL42024-09-17
PBJ22023-11-21
PPT22020-08-31
DZJ22019-03-11
DZE22004-05-28
ELE12022-07-08
HAE12022-06-03
PBF12020-03-11
HWC12016-12-19
JDQ12016-04-06
GWO12013-01-17
JEC12004-08-25
NEI12001-07-27

PMN#

54 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next