Paradigm Spine GmbH
Wurmlingen Baden-Wurttemberg, DE
Paradigm Spine GmbH appears in FDA device records in Wurmlingen Baden-Wurttemberg, DE. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for Paradigm Spine GmbH between 2008 and 2022. The busiest year on record is 2008, with 4. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 4 |
| 2009 | 3 |
| 2010 | 2 |
| 2012 | 3 |
| 2016 | 1 |
| 2020 | 2 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213493 | Fortilink with TiPlus Technology | ODP | Substantially Equivalent | |
| K201453 | Fortilink Cages with TiPlus Technology | MAX | Substantially Equivalent | |
| K201704 | CoFix System | PEK | Substantially Equivalent | |
| K153302 | coflex-IF | PEK | Substantially Equivalent | |
| K120491 | DSS STABILIZATION SYSTEM-RIGID | MNH | Unknown | |
| K112595 | COFLEX-F | KWP | Substantially Equivalent | |
| K113625 | DSS STABILIZATION SYSTEM | NKB | Unknown | |
| K093438 | PARADIGM INTERSPINOUS FUSION PLATE | KWP | Substantially Equivalent | |
| K101083 | DSS STABILIZATION SYSTEM | NQP | Unknown | |
| K091944 | MODIFICATION TO: DSS STABILIZATION SYSTEM | NQP | Substantially Equivalent | |
| K090099 | DSS STABILIZATION SYSTEM | NKB | Unknown | |
| K090408 | MODIFICATION TO: DSS STABILIZATION SYSTEM | NKB | Unknown | |
| K080241 | DDS STABILIZATION SYSTEM | NQP | Unknown | |
| K071668 | ORTHOBIOM SPINAL SYSTEM | MNI | Substantially Equivalent | |
| K080963 | DSS STABILIZATION SYSTEM | NQP | Substantially Equivalent | |
| K072969 | DSS | NQP | Unknown |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005426761 | 3005426761 | Paradigm Spine GmbH | Eisenbahnstrabe 84, Wurmlingen Baden-Wurttemberg 78573 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- NQPPosterior Metal/Polymer Spinal System, Fusion
- NQOProsthesis, Spinous Process Spacer/Plate
- PEKSpinous Process Plate
- NKBThoracolumbosacral Pedicle Screw System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain