FDA.reportPublic FDA data

ORTHOPEDIATRICS CANADA ULC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30003274453000327445ORTHOPEDIATRICS CANADA ULC1N2026-01-011111 Chomedey Highway (A13) Laval Quebec CA H7W 5J8

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
07540194018168Dr.Paleys Osteotomy System - Dr PALEY OSTEOTOME 6 mm+1(450)688-5144egarcia@pegamedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
971461666102038K241983Fassier-Duval Telescoping IM SystemHSB2025-02-21
971461801799885K220190The GIRO Growth Modulation SystemOBT2022-10-24
971461577375844K211292Fassier-Duval Telescopic IM SystemHSB2021-05-26
971461413516976K192710The Simple Locking Intramedullary (Slim) SystemHSB2020-06-24
971461267903169K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemKTT2017-09-08
971461678185389K163003Y3 Proximal Femoral Plate SystemHRS2017-03-16
971462059308542K160545GAP ENDO-EXO MEDULLARY SYSTEMHSB2016-11-23
971461211840281K143355The Simple Locking IntraMedullary (SLIM) SystemHSB2015-07-10
971461745539860K131591FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)HWC2013-11-27
971461235222081K111232GAP ENDO-EXO MEDULLARY SYSTEMHSB2012-01-26
971461465793698K090440HINGE PEDIATRIC PLATING SYSTEMHRS2009-05-20
971461793946798K041393FASSIER-DUVAL TELSCOPIC IM SYSTEMHSB2004-08-17
971461349637987K020885FASSIRE-DUVAL TELESCOPIC IM SYSTEMHSB2003-02-06
971461008003739
971461769684112
971461231234391
971461265885977
971461312638172
971461340783239
971461431647124
971461569508779
971461584301730
971461713015839
971461795865539
971461822161523

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HSB122025-02-21
HRS42017-03-16
KTT22017-09-08
HWC22013-11-27
OBT12022-10-24

GUDID#