FDA Registration
Active
🇨🇦 Canada
ORTHOPEDIATRICS CANADA ULC
Reg #: 3000327445
·
FEI: 3000327445
·
Expires 2026
Products
16
Proprietary Names
27
Establishment Types
1
Classifications
16
Registration Details
- Registration Name
- ORTHOPEDIATRICS CANADA ULC
- Registration Number
- 3000327445
- FEI Number
- 3000327445
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1111 Chomedey Highway (A13)
- City
- Laval Quebec
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K111232
Owner / Operator
- Firm Name
- Pega Medical Inc.
- Operator Number
- 10027933
- Address
- 1111 Highway 13 Autoroute Chomedey
- City
- Laval
- State
- Quebec
- Postal Code
- H7W 5J8
- Country
- CA
- Correspondent
- Enrique Garcia
US Agent
- Business Name
- OrthoPediatrics Corp.
- Contact Name
- Ray Garrison
- Address
- 2850 Frontier Dr
- City
- Warsaw
- State
- IN
- ZIP
- 46582
- Country
- US
- [email protected]
- Phone
- 574 2686379
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2012-02-14 |
| Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | OBT | Class 2 | Orthopedic | No | 2022-11-18 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-11-18 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2025-05-21 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2025-05-21 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2009-06-26 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2018-12-06 |
| Bone Mill | LYS | Class 1 | Orthopedic | No | 2025-05-21 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2025-05-20 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2025-05-20 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2025-05-21 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2025-05-21 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2017-09-11 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2025-05-20 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2025-05-21 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2025-05-20 |
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
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
Hinge Pediatric Plating System
The Locking Pediatric Osteotomy Plate (Lollipop) System
Fassier-Duval Telescopic IM System
Establishment Types
Manufacture Medical Device