Data / Medical devices / Germany / Paradigm Spine GmbH
Paradigm Spine GmbH: FDA-registered device maker in Wurmlingen Baden-Wurttemberg, Germany, 3 510(k) clearances and 1 PMA approval
Paradigm Spine GmbH is registered with the FDA (registration 3005426761) in Wurmlingen Baden-Wurttemberg, Germany. It lists 3 device types. The FDA files 3 510(k) clearances and 1 PMA approval under its listings, the newest dated August 4, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005426761
- Address
- Eisenbahnstrabe 84, Wurmlingen Baden-Wurttemberg, Germany, 78573
- Owner or operator
- Companion Spine (10086759)
- Roles
- Specification developer
- First device listed
- December 4, 2025
- Registered through
- 2026
- Brand names listed
- Cofix System, Coflex Interlaminar Technology, Coflex-F Implant System, Coflex-IF
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Specification developer | accessdata.fda.gov |
| Prosthesis, Spinous Process Spacer/Plate | NQO | 3 | Specification developer | accessdata.fda.gov |
| Spinous Process Plate | PEK | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 4, 2020 | K201704 | CoFix System | PEK | Substantially Equivalent | Paradigm Spine GmbH | accessdata.fda.gov |
| September 8, 2016 | K153302 | coflex-IF | PEK | Substantially Equivalent | Paradigm Spine, LLC | accessdata.fda.gov |
| February 13, 2012 | K112595 | COFLEX-F | KWP | Substantially Equivalent | Paradigm Spine, LLC | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| October 17, 2012 | P110008 | COFLEX® INTERLAMINAR TECHNOLOGY | NQO | 14 | May 22, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Appliance, Fixation, Spinal Interlaminal
- All makers of Prosthesis, Spinous Process Spacer/Plate
- All makers of Spinous Process Plate
Updated May 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.