CarboFix Orthopedics, Ltd.
✅ Low Risk
FEI: 3008820440 • Herzliya, Hamerkaz • ISRAEL
FEI Number
3008820440
Location
Herzliya, Hamerkaz
Country
ISRAELAddress
11 Ha, Hoslim St., , Herzliya, Hamerkaz, Israel
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 |
|---|---|---|---|
| 3/11/2016 | 87HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is CarboFix Orthopedics, Ltd.'s FDA import refusal history?
CarboFix Orthopedics, Ltd. (FEI: 3008820440) has 1 FDA import refusal record(s) in our database, spanning from 3/11/2016 to 3/11/2016.
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. CarboFix Orthopedics, Ltd.'s FEI number is 3008820440.
What types of violations has CarboFix Orthopedics, Ltd. received?
CarboFix Orthopedics, Ltd. 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 CarboFix Orthopedics, Ltd. come from?
All FDA import refusal data for CarboFix Orthopedics, Ltd. 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.