ORTHOPEDIATRICS CANADA ULC

FDA Device Registration & Listing · Laval Quebec, CA · Registration 3000327445

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3000327445
FEI Number
3000327445
Entity Name
ORTHOPEDIATRICS CANADA ULC
City/State/Country
Laval Quebec, CA
Establishment Address
1111 Chomedey Highway (A13), Laval Quebec H7W 5J8, CA
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Pega Medical Inc. (Owner Number: 10027933)
Owner / Operator Contact Address
1111 Highway 13 Autoroute Chomedey, Laval, CA-QC H7W 5J8, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Gap Endo-Exo Medullary System The Simple Locking IntraMedullary (SLIM) System Fassier-Duval Telscopic Im System The GIRO Growth Modulation System Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe) GAP Endo-Exo Medullary System Dr.Paleys Osteotomy System THE LOCKING PEDIATRIC OSTEOTOMY PLATE (LOLLIPOP) SYSTEM HINGE PEDIATRIC PLATING SYSTEM GAP ENDO-EXO MEDULLARY SYSTEM FASSIER-DUVAL TELESCOPIC IM SYSTEM SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM GIRO GROWTH MODULATION SYSTEM FREE GLIDING SCFE SCREW SYSTEM Fassier-Duval Telscopic Im System Instruments Dr.Paleys Osteotomy System The Simple Locking Intramedullary (Slim) System Instruments Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe) Instruments Gap Endo-Exo Medullary System Instruments Y3 Proximal Femoral Plate System Instruments The Locking Pediatric Osteotomy Plate (Lollipop) System Instruments Hinge Pediatric Plating System Instruments The Simple Locking Intramedullary (Slim) System Y3 Proximal Femoral Plate System Fassier-Duval Telescoping IM System GAP ENDO-EXO MEDULLARY SYSTEM FASSIER-DUVAL TELESCOPIC IM SYSTEM Fassier-Duval Telscopic Im System Hinge Pediatric Plating System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2012-02-14
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2023-12-21
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2008-12-16
OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis Orthopedic Class 2 888.3030 2022-11-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-11-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-12-11
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2024-07-19
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2025-05-21
HXX Screwdriver Orthopedic Class 1 888.4540 2025-05-21
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2009-06-26
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2015-09-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-12-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-12-06
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-02-24
LYS Bone Mill Orthopedic Class 1 888.4540 2025-05-21
HWK Trephine Orthopedic Class 1 888.4540 2025-05-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2008-12-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2009-06-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2009-06-26

Official Correspondent

Enrique Garcia

US Agent Details

Ray Garrison Business: OrthoPediatrics Corp. Email: rgarrison@orthopediatrics.com Phone: (574) 2686379

Related Public Records

Same Entity

Pega Medical Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K040336 Synthes (Usa) SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM 2004-04-12
K083648 Efratgo, Ltd. HI Tech Bio-Surgical GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL 2009-05-14
K192312 Zimmer GmbH Zimmer Natural Nail System Cephalomedullary Nails 2019-10-11
K002057 Biomet Orthopedics, Inc. BROOKER TIBIA NAILS 2000-10-04
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000327445. Last updated year: 2026. Please use registration number 3000327445 when referencing this establishment in official correspondence.
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