Linvatec Corp. dba ConMed Linvatec
⚠️ Moderate Risk
FEI: 1017294 • Largo, FL • UNITED STATES
FEI Number
1017294
Location
Largo, FL
Country
UNITED STATESAddress
11311 Concept Blvd, , Largo, FL, United States
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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/5/2025 | 76DZIDRILL, BONE, POWERED | Division of Southeast Imports (DSEI) | |
| 5/31/2019 | 79HABSAW, POWERED, AND ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 5/31/2019 | 79HABSAW, POWERED, AND ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/30/2019 | 79NEHANCHOR, FASCIAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/14/2018 | 79HABSAW, POWERED, AND ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 3/14/2018 | 76DZIDRILL, BONE, POWERED | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 9/27/2013 | 87HRXARTHROSCOPE AND ACCESSORIES | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Linvatec Corp. dba ConMed Linvatec's FDA import refusal history?
Linvatec Corp. dba ConMed Linvatec (FEI: 1017294) has 7 FDA import refusal record(s) in our database, spanning from 9/27/2013 to 9/5/2025.
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. Linvatec Corp. dba ConMed Linvatec's FEI number is 1017294.
What types of violations has Linvatec Corp. dba ConMed Linvatec received?
Linvatec Corp. dba ConMed Linvatec has been cited for 4 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 Linvatec Corp. dba ConMed Linvatec come from?
All FDA import refusal data for Linvatec Corp. dba ConMed Linvatec 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.