Stryker Latin America
✅ Low Risk
FEI: 3000205422 • Miami Lakes, FL • UNITED STATES
FEI Number
3000205422
Location
Miami Lakes, FL
Country
UNITED STATESAddress
15100 NW 67th Ave Ste 210, , Miami Lakes, FL, United States
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/5/2005 | 87KWJPROSTHESIS, ELBOW, HEMI-, HUMERAL, METAL | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Stryker Latin America's FDA import refusal history?
Stryker Latin America (FEI: 3000205422) has 1 FDA import refusal record(s) in our database, spanning from 5/5/2005 to 5/5/2005.
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. Stryker Latin America's FEI number is 3000205422.
What types of violations has Stryker Latin America received?
Stryker Latin America 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 Stryker Latin America come from?
All FDA import refusal data for Stryker Latin America 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.