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: CoFix™ implant, 8mm, DCI™ implant, HPS™ 2.0 Polyaxial pedicle screw, HPS™ 2.0 Polyaxial pedicle screw, MIS, HPS™ 2.0 Polyaxial pedicle screw, MIS Ø4.5 x 25mm.
Among these devices, 174 are declared sterile, 176 implantable, 197 reusable, 9 with a measuring function.
Devices declared under this manufacturer
- CoFix™
- DCI™
- DCI™ implant
- DCI™ implant,
- DSS™
- Fortilink™
- HPS™ 2.0
- coflex®
- coflex® Extractor pliers
Showing 12 of 435 declared devices.
Catalogue references include CBI12146, HBI66555, HBI68560, HBI88545, HBI89555, HBT90220.
European nomenclature codes declared: L091199, P09070302, P09070305, S010399, L091103, L1299.
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 |
Device-level evidence
| Devices with a numeric GTIN | 435 |
|---|---|
| Found in the U.S. device database | 139 |
| Share | 32.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | PARADIGM SPINE GMBH |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 1 |
| First licensed | 2006-10-20 |
Licence types: Single Device (1).
Licensed under: COFLEX INTERLAMINAR IMPLANT.
North American profile: Both markets. Paradigm Spine GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G70 057034 0023 | issued | 2031-07-09 |
G15 057034 0022 | supplemented | 2031-07-06 |