Orthofix Srl
⚠️ Moderate Risk
FEI: 3002807827 • Bussolengo, Verona • ITALY
FEI Number
3002807827
Location
Bussolengo, Verona
Country
ITALYAddress
Via Delle Nazioni 9, , Bussolengo, Verona, Italy
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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 |
|---|---|---|---|
| 6/30/2011 | 87NDJSCREW, FIXATION, BONE, NON-SPINAL, METALLIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87NDJSCREW, FIXATION, BONE, NON-SPINAL, METALLIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87MRYAPPLIANCES AND ACCESSORIES, FIXATION, BONE, ABSORBABLE SINGLE/MULTIPLE COMPONENT | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87NDJSCREW, FIXATION, BONE, NON-SPINAL, METALLIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87JDPIMPLANT, FIXATION DEVICE, CONDYLAR PLATE | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87JDSNAIL, FIXATION, BONE | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87NDJSCREW, FIXATION, BONE, NON-SPINAL, METALLIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87NDJSCREW, FIXATION, BONE, NON-SPINAL, METALLIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87JDSNAIL, FIXATION, BONE | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87NDJSCREW, FIXATION, BONE, NON-SPINAL, METALLIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87JDSNAIL, FIXATION, BONE | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87JDSNAIL, FIXATION, BONE | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87LYTFIXATION ACCESSORY | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87LYTFIXATION ACCESSORY | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87NDJSCREW, FIXATION, BONE, NON-SPINAL, METALLIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87HXCWRENCH | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87JDPIMPLANT, FIXATION DEVICE, CONDYLAR PLATE | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87MRYAPPLIANCES AND ACCESSORIES, FIXATION, BONE, ABSORBABLE SINGLE/MULTIPLE COMPONENT | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87LYTFIXATION ACCESSORY | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87NDJSCREW, FIXATION, BONE, NON-SPINAL, METALLIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87MRYAPPLIANCES AND ACCESSORIES, FIXATION, BONE, ABSORBABLE SINGLE/MULTIPLE COMPONENT | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87JDSNAIL, FIXATION, BONE | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87NDJSCREW, FIXATION, BONE, NON-SPINAL, METALLIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87JDSNAIL, FIXATION, BONE | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87JDSNAIL, FIXATION, BONE | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87MRYAPPLIANCES AND ACCESSORIES, FIXATION, BONE, ABSORBABLE SINGLE/MULTIPLE COMPONENT | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87NDJSCREW, FIXATION, BONE, NON-SPINAL, METALLIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87MRYAPPLIANCES AND ACCESSORIES, FIXATION, BONE, ABSORBABLE SINGLE/MULTIPLE COMPONENT | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87MRYAPPLIANCES AND ACCESSORIES, FIXATION, BONE, ABSORBABLE SINGLE/MULTIPLE COMPONENT | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87MRYAPPLIANCES AND ACCESSORIES, FIXATION, BONE, ABSORBABLE SINGLE/MULTIPLE COMPONENT | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87JDSNAIL, FIXATION, BONE | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87JDSNAIL, FIXATION, BONE | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87JDSNAIL, FIXATION, BONE | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87JDSNAIL, FIXATION, BONE | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87NDJSCREW, FIXATION, BONE, NON-SPINAL, METALLIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87NDJSCREW, FIXATION, BONE, NON-SPINAL, METALLIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87HWCSCREW, FIXATION, BONE | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87NDFPLATE, FIXATION, BONE, NON-SPINAL, METALLIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87MRYAPPLIANCES AND ACCESSORIES, FIXATION, BONE, ABSORBABLE SINGLE/MULTIPLE COMPONENT | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87LYTFIXATION ACCESSORY | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87MRYAPPLIANCES AND ACCESSORIES, FIXATION, BONE, ABSORBABLE SINGLE/MULTIPLE COMPONENT | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87MRYAPPLIANCES AND ACCESSORIES, FIXATION, BONE, ABSORBABLE SINGLE/MULTIPLE COMPONENT | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87NDJSCREW, FIXATION, BONE, NON-SPINAL, METALLIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87MRYAPPLIANCES AND ACCESSORIES, FIXATION, BONE, ABSORBABLE SINGLE/MULTIPLE COMPONENT | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/30/2011 | 87MRYAPPLIANCES AND ACCESSORIES, FIXATION, BONE, ABSORBABLE SINGLE/MULTIPLE COMPONENT | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/30/2002 | 87MOOORTHOPEDIC IMPLANT MATERIAL | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Orthofix Srl's FDA import refusal history?
Orthofix Srl (FEI: 3002807827) has 46 FDA import refusal record(s) in our database, spanning from 9/30/2002 to 6/30/2011.
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. Orthofix Srl's FEI number is 3002807827.
What types of violations has Orthofix Srl received?
Orthofix Srl has been cited for 2 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 Orthofix Srl come from?
All FDA import refusal data for Orthofix Srl 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.