Ortho Cape
FR-MF-000028862 · France · Montauban
Ortho Cape is registered in the European database on medical devices as a manufacturer, with 256 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 214 |
|---|---|
| Class IIa | 42 |
Most frequent device types declared: ARTHROSTAB, BURR, DRILL, EAGLE, MI-SCREW.
Among these devices, 221 are declared sterile, 214 implantable, 32 reusable, 1 active.
Devices declared under this manufacturer
- ARTHROSTAB Screw Ø4.6 Lg 50mm
- ARTHROSTAB Screw Ø4.6 Lg 54mm
- ARTHROSTAB Screw Ø7 Lg 90mm
- Drill for Mi-Screw Ø 3mm
- EAGLE Screw Ø4.6 Lg 24mm
- EAGLE Screw Ø7 16 MM Thread Lg 55MM
- EAGLE Screw Ø7 28MM Thread Lg90MM
- MI SCREW Ø4 lg 34mm
- MI SCREW Ø4 lg 38mm
- PIN WITH BALL Ø1,2
- PPDA Screw Ø 2.6 lg 32mm
- Screwdriver Blade Eagle/ Arthrostab 4.6
Showing 12 of 256 declared devices.
Catalogue references include 14.30.17, 38.23.38, 38.49.32, 38.63.14/18, 38.98.24, 38.99.55A.
European nomenclature codes declared: P09120603, P09120699, P09120301, L26, Z12130503, Q030302.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ORTHO CAPE (FR) · FDA 3027827832 |
| Devices in EUDAMED | 256 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 256 |
|---|---|
| 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: United States only. Ortho Cape is registered in the United States but was not found in the Canadian register.