ProSpon, spol. s r.o.
CZ-MF-000019992 · Czechia · Kladno
ProSpon, spol. s r.o. is registered in the European database on medical devices as a manufacturer, with 264 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 161 |
|---|---|
| Class IIb | 102 |
| Class I | 1 |
Among these devices, 23 are declared sterile, 103 implantable.
Devices declared under this manufacturer
- Conical pin Ø 4.5mm, thread 2.5/3mm, L 70/10 mm
- Conical pin Ø 6mm, thread 6/5mm, L 220/50 mm
- Hamstring screw 60mm
- Hlava kolmá
- Hlava přímá dětská PH-FIX
- Interference screw 7/20
- Interference screw 7/30
- Interference screw 9/30
- Jezdec plast 8/8
- Kruh carbon 180mm
- Kruh carbon 220mm
- Tyč carbon Ø 8/400
Showing 12 of 264 declared devices.
Catalogue references include F0010300, F0012100, F0025800, F0060101, S0010307, S0030700.
European nomenclature codes declared: P0912040101, P09120499, P09120605, P900401, P09120699, P090403.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 264 |
| Country of registration | Czechia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 264 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. ProSpon, spol. s r.o. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2026-MDR/TD-003 | issued | 2029-04-26 |
2026-MDR/QS-032 | issued | 2031-05-22 |
2026-MDR/QS-003 | issued | 2029-04-26 |