ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
✅ Low Risk
FEI: 3000327445 • Laval, Quebec • CANADA
FEI Number
3000327445
Location
Laval, Quebec
Country
CANADAAddress
1111 Chomedey (A-13) E, , Laval, Quebec, Canada
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL's FDA import refusal history?
ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL (FEI: 3000327445) has 2 FDA import refusal record(s) in our database, spanning from 6/15/2012 to 10/11/2013.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL's FEI number is 3000327445.
What types of violations has ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL received?
ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL come from?
All FDA import refusal data for ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.