FDA.reportPublic FDA data

ORTHOPEDIATRICS CANADA ULC

Matched from indexed company URL: ORTHOPEDIATRICS CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30003274453000327445ORTHOPEDIATRICS CANADA ULC1N2026-01-011111 Chomedey Highway (A13) Laval Quebec CA H7W 5J8
30064601623006460162ORTHOPEDIATRICS, CORP1Y2026-01-012850 Frontier Dr Warsaw IN US 46582

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
00840536822543Prone Perfect - Prone Perfect Pelvic Base+1(574)268-6379xxx@xxx.com
00840536822550Prone Perfect - Prone Perfect Thoracic Base+1(574)268-6379xxx@xxx.com
00840536822567Prone Perfect - Prone Perfect Rib Pad Base+1(574)268-6379xxx@xxx.com
00840536822574Prone Perfect - Prone Perfect Pelvic Pad+1(574)268-6379xxx@xxx.com
00840536822581Prone Perfect - Prone Perfect Thoracic Pad+1(574)268-6379xxx@xxx.com
00840536822598Prone Perfect - Prone Perfect Rib Pad+1(574)268-6379xxx@xxx.com
00840536822604Prone Perfect - Prone Perfect Angle Pad+1(574)268-6379xxx@xxx.com
00840536822611Prone Perfect - Prone Perfect Bolt, Long+1(574)268-6379xxx@xxx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
939351491551805K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemHRS2026-04-30
939351549977782K252600Pediatric Plating Platform I Small-MiniHRS2025-10-09
939351794010577K251362PediFlex™ Flexible Nail SystemHTY2025-06-24
939351423980545K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurHSB2025-04-01
939351694521312K243963Pediatric Plating Platform HipHRS2025-04-29
939351327828468K243798Orthex External Fixation SystemKTT2025-03-07
971461666102038K241983Fassier-Duval Telescoping IM SystemHSB2025-02-21
939351106305471K241816VerteGlide Spinal Growth Guidance SystemPGM2025-03-14
939351902632955K233105RESPONSE™ Rib and Pelvic SystemMDI2024-01-20
939351736227170K231266Pediatric Nailing Platform TibiaHSB2023-08-21
939351107497227K223786Orthex External Fixation SystemKTT2023-02-10
939351289236799K222105RESPONSE 5.5/6.0 Cannulated Screw SystemNKB2023-03-23
939351296235856K220809Drive Rail SystemKTT2022-04-08
939351556863614K220679Pediatric Nailing Platform FemurHSB2022-07-20
971461801799885K220190The GIRO Growth Modulation SystemOBT2022-10-24
971461577375844K211292Fassier-Duval Telescopic IM SystemHSB2021-05-26
939351585688008K203573RESPONSE Navigation InstrumentsOLO2021-02-04
939351232318184K201838PediFlex Flexible Nail SystemHTY2021-01-29
939351576616343K200097Response BandLoc Spinal FixationOWI2020-03-16
939351369978741K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemNKB2020-03-24
971461413516976K192710The Simple Locking Intramedullary (Slim) SystemHSB2020-06-24
939351550395593K190992OrthoPediatrics PediFoot Deformity Corrections SystemHRS2019-08-06
939351747633763K190324OrthoPediatrics Cannulated Screw SystemHWC2019-07-05
939351694250791K190321Pediatric Nailing PlatformFemurHSB2019-10-09
939351081739391K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemNKB2018-09-18
939351459874621K172583OrthoPediatrics PediNail Intramedullary PlatformHSB2018-05-10
939351289979989K172425OrthoPediatrics Wrist Fusion PlateHRS2017-12-06
939352063943771K171173OrthoPediatrics Titanium PediPlates® SystemHRS2017-08-24
971461267903169K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemKTT2017-09-08
939351062019129K163487Ultima HA Coated Half Pins and WireJDW2017-02-13
971461678185389K163003Y3 Proximal Femoral Plate SystemHRS2017-03-16
939351764824219K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsHRS2016-09-27
939351528106639K161267Response BandLoc Spinal FixationOWI2016-08-11
971462059308542K160545GAP ENDO-EXO MEDULLARY SYSTEMHSB2016-11-23
939351693230678K160466Response 5.5 Spine SystemNKB2016-03-23
939351324243078K151881X-Fix Line AdditionsKTT2016-03-24
939351382439503K150600Response 5.5/6.0 Spine SystemNKB2015-05-22
971461211840281K143355The Simple Locking IntraMedullary (SLIM) SystemHSB2015-07-10
939352033504889K140822DRIVE RAIL SYSTEMKTT2014-05-29
939351032066679K140431PEDILOC FRAGMENT SYSTEMHRS2014-07-29
939351688419899K132820VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRESJDW2014-07-23
971461745539860K131591FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)HWC2013-11-27
939351644751185K130655RESPONSE SPINE SYSTEMOSH2013-05-08
939351381938188K130217ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEMMBI2013-06-20
939351797323674K121250OP SPINE SYSTEMOSH2012-06-19
939351818430165K120291OP SPINE SYSTEMOSH2012-04-16
971461235222081K111232GAP ENDO-EXO MEDULLARY SYSTEMHSB2012-01-26
939351272467335K111086ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEMHRS2011-06-17
939352060496697K110959ORTHOPEDIATRICS BLADE PLATE SYSTEMHRS2011-08-05
939351849045595K100240ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEMHRS2010-05-17
939351538048397K090666PEDIPLATESHRS2009-04-24
971461465793698K090440HINGE PEDIATRIC PLATING SYSTEMHRS2009-05-20
939351432905046K083726PEDINAIL INTRAMEDULLARY NAILING SYSTEMHSB2009-03-11
939351305291109K083286ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEMHRS2009-01-30
939351310926414K082949ORTHOPEDIATRICS BONE SCREWSHWC2008-11-25
939351214919397K082375ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEMHTY2008-10-17
939351554760348K081407ORTHOPEDIATRICS PEDIPLATES SYSTEMHRS2008-07-22
939351154743288K081097ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEMHTY2008-06-03
939351918875803K073344ORTHOPEDIATRICS PLATING SYSTEMHRS2008-02-19
939351638811766K052196VILEX X-FIXKTT2005-11-22
971461793946798K041393FASSIER-DUVAL TELSCOPIC IM SYSTEMHSB2004-08-17
939351504553420K031050PCW PERCUTANEOUS COMPRESSION WIREHWC2003-07-14
971461349637987K020885FASSIRE-DUVAL TELESCOPIC IM SYSTEMHSB2003-02-06
971461008003739
971461769684112
939351044242331
939351087572316
939351102738963
939351110763927
939351112060154
939351162860876
939351206273562
971461231234391
939351255003439
971461265885977
939351268245073
939351309593642
971461312638172
971461340783239
939351398885534
939351409792919
971461431647124
939351457773584
939351477939944
939351567362970
971461569508779
939351571157421
971461584301730
939351601114817
939351614035094
939351614884454
939351630034620
939351631552406
939351642404886
939351645139017
939351656077904
939351664569042
939351673252472
939351692002019
971461713015839
939351720371318
939351756018047
939351771934115
939351776871260
971461795865539
939351815025034
971461822161523
939351824104549
939351826486927
939351834510164
939351847353872

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS192026-04-30
HSB182025-04-01
KTT82025-03-07
NKB52023-03-23
HWC52019-07-05
HTY42025-06-24
OSH32013-05-08
OWI22020-03-16
JDW22017-02-13
PGM12025-03-14
MDI12024-01-20
OBT12022-10-24
OLO12021-02-04
MBI12013-06-20

PMN#

42 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next