Paradigm Spine GmbH
DE-MF-000011231 · Germany · Wurmlingen
Paradigm Spine GmbH is registered in the European database on medical devices as a manufacturer, with 435 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 259 |
|---|---|
| Class IIb | 164 |
| Class I | 12 |
Most frequent device types declared: HPS™ 2.0 Polyaxial pedicle screw, HPS™ Rod Set, pre-bent, HPS™ 2.0 Polyaxial pedicle screw, MIS, DCI™ implant, HPS™ Rod Set, straight.
Among these devices, 174 are declared sterile, 176 implantable, 197 reusable, 9 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Paradigm Spine GmbH (DE) · FDA 3005426761 |
| Devices in EUDAMED | 435 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G70 057034 0023 | issued | 2031-07-09 |
G15 057034 0022 | supplemented | 2031-07-06 |