FDA.reportPublic FDA data

Ortho Solutions LC

Matched from indexed company URL: ORTHO SOLUTIONS LIMITED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
19371001937100Ortho Solutions LC1N2026-01-018050 Hawk Ridge Trail Lake Saint Louis MO US 63367
30098121903022270316Ortho Solutions Inc1Y2026-01-01209 10th Avenue S Ste. 416 Nashville TN US 37203
30127559883012755988Ortho Solutions Sdn Bhd1N2026-01-012821, Tingkat Perusahaan 5A Prai Industrial Estate Prai, Penang Pulau Pinang MY 13600

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
05055662971460ORTHO SOLUTIONS SUCCESSION AFN SYSTEM - 6MM X 50MM P/A CORTICAL SCREW+4401621874378regulatory@orthosol.com
05055662971477ORTHO SOLUTIONS SUCCESSION AFN SYSTEM - 6MM X 55MM P/A CORTICAL SCREW+4401621874378regulatory@orthosol.com
05055662971484ORTHO SOLUTIONS SUCCESSION AFN SYSTEM - 6MM X 60MM P/A CORTICAL SCREW+4401621874378regulatory@orthosol.com
05055662971491ORTHO SOLUTIONS SUCCESSION AFN SYSTEM - 6MM X 65MM P/A CORTICAL SCREW+4401621874378regulatory@orthosol.com
05055662971507ORTHO SOLUTIONS SUCCESSION AFN SYSTEM - 6MM X 70MM P/A CORTICAL SCREW+4401621874378regulatory@orthosol.com
05055662971521ORTHO SOLUTIONS SUCCESSION AFN SYSTEM - 6MM X 80MM P/A CORTICAL SCREW+4401621874378regulatory@orthosol.com
05055662971538ORTHO SOLUTIONS SUCCESSION AFN SYSTEM - 6MM X 115MM P/A CORTICAL SCREW+4401621874378regulatory@orthosol.com
05055662971545ORTHO SOLUTIONS SUCCESSION AFN SYSTEM - 6MM X 120MM P/A CORTICAL SCREW+4401621874378regulatory@orthosol.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
338031100921902K955292AELITEFLOEBF1995-12-13
1468181242068727K250622Succession™ AFN SystemHSB2025-08-07
1468182033150338K240212COGNiTiON™ Staple SystemJDR2024-02-23
338031073410833K230225DynaFlex Clear Brackets & ButtonsNJM2023-06-05
338032056708751K214096Respire ClearLRK2022-05-31
1468181461680614K210658Volition Plating SystemHRS2021-04-13
1468181273351772K202764Ortho Solutions Plating SystemHRS2020-11-20
338031984746580K192127Respire Pink AT (Hard, Hard/Soft, EF)LRK2020-02-05
338031732107972K190583DynaFlexNXC2019-06-27
338031200584666K170692Respire Pink Series with DentiTracLRK2017-05-26
338031680835780K152292Respire Blue Series-EFLRK2015-12-07
338031984632665K150572Respire Pink Series-Herbst-EFLRK2015-08-27
338031016108746K141421PMMA BLOCKEBG2015-02-09
338031476391297K131138RESPIRE PINK SERIES - HERBSTLRK2013-09-09
1468181424055328K121575OXFORD ANKLE FUSION NAIL(AFN) SYSTEMHSB2012-09-14
338032034189390K120471MACH BRACKETS BRIGHT BRACKETSNJM2012-06-04
338032016417807K111207RESPIRE BLUE SERIESLRK2011-08-23
338031011260764K103076DYNAFLEXLRK2011-02-23
1468181467851697K102743ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRESHWE2011-01-20
338031204620927K090567ORTHODONTIC CERAMIC BRACKETNJM2009-05-27
338031550275849K082408LEDEX, MODEL: WL-070EBZ2008-12-03
2831231006392322
2831231016328080
2831231019348486
338031035688683
2831231042367937
2831231061451558
338031067694808
2831231080886662
2831231086721887
338031117471225
2831231131606673
338031139783634
2831231145409090
338031146164879
338031187389927
338031199779377
338031212705448
2831231219860531
338031229365431
338031232958698
338031236511401
2831231239016242
338031239613489
338031241606103
338031243254364
338031245532727
2831231247799475
2831231268243869
338031287501368
338031303530611
2831231313052085
2831231328908853
2831231337383764
2831231350811791
2831231362278381
338031368087557
338031378086531
2831231380598820
2831231384070075
338031405839258
338031416319201
2831231420573198
2831231421715519
338031427191414
2831231446454619
338031453900084
2831231481196166
2831231515005763
338031568020529
2831231573528313
338031573869522
338031587621345
2831231588299534
2831231598838138
2831231626473530
338031635044541
338031638997007
2831231645083125
338031647484216
2831231720012641
2831231744530176
2831231761141310
338031761414462
2831231808688014
338031818893403
2831231820605875
2831231850960059
2831231884590298
2831231902954581
338031905551900
338031936622318
338031954859063
338031956254719
338031969771840
2831231973825873
338031974809371
338031980525201
338031983121125
338031986951591
338032010834304
2831232019992730
338032029316577
338032047357393
338032058199318

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LRK82022-05-31
NJM32023-06-05
HSB22025-08-07
HRS22021-04-13
JDR12024-02-23
NXC12019-06-27
EBG12015-02-09
HWE12011-01-20
EBZ12008-12-03
EBF11995-12-13

PMN#

GUDID#

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