Paradigm Spine Gmbh
⚠️ Moderate Risk
FEI: 3005426761 • Wurmlingen, Baden-Wurttemberg • GERMANY
FEI Number
3005426761
Location
Wurmlingen, Baden-Wurttemberg
Country
GERMANYAddress
Eisenbahnstr. 84, , Wurmlingen, Baden-Wurttemberg, Germany
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
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(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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/28/2020 | 79GFCDRIVER, SURGICAL, PIN | Division of Northern Border Imports (DNBI) | |
| 12/28/2020 | 79GFCDRIVER, SURGICAL, PIN | Division of Northern Border Imports (DNBI) | |
| 12/28/2020 | 79GFCDRIVER, SURGICAL, PIN | Division of Northern Border Imports (DNBI) | |
| 12/28/2020 | 79PXNBASIC SET-UP TRAY | Division of Northern Border Imports (DNBI) | |
| 12/28/2020 | 79GFJMALLET, SURGICAL, GENERAL & PLASTIC SURGERY | Division of Northern Border Imports (DNBI) | |
| 12/28/2020 | 79HTCPLIERS, SURGICAL | Division of Northern Border Imports (DNBI) | |
| 12/28/2020 | 79HTCPLIERS, SURGICAL | Division of Northern Border Imports (DNBI) | |
| 11/25/2020 | 87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE | Division of Southeast Imports (DSEI) | |
| 8/15/2016 | 87KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/15/2016 | 87KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/15/2016 | 87KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/15/2016 | 87KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/15/2016 | 87KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/15/2016 | 87KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/15/2016 | 87KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/15/2016 | 87KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/15/2016 | 87KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/15/2016 | 87KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/15/2016 | 87KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/15/2016 | 87KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/15/2016 | 87KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/27/2007 | 87HXBPROBE | New Orleans District Office (NOL-DO) | |
| 6/27/2007 | 87JDNIMPLANT, FIXATION DEVICE, SPINAL | New Orleans District Office (NOL-DO) | |
| 6/27/2007 | 55DY99METALLIC CONTAINERS AND MATERIAL, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Paradigm Spine Gmbh's FDA import refusal history?
Paradigm Spine Gmbh (FEI: 3005426761) has 24 FDA import refusal record(s) in our database, spanning from 6/27/2007 to 12/28/2020.
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. Paradigm Spine Gmbh's FEI number is 3005426761.
What types of violations has Paradigm Spine Gmbh received?
Paradigm Spine Gmbh 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 Paradigm Spine Gmbh come from?
All FDA import refusal data for Paradigm Spine Gmbh 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.