LIMACORPORATE S.p.A.
IT-MF-000010690 · Italy · Villanova di San Daniele del Friuli
LIMACORPORATE S.p.A. is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 7 |
|---|---|
| Class IIa | 4 |
Most frequent device types declared: 80333902A016BP, 80333902A040BL, DELTA SPACER, DELTA-ONE-TT CUP, LOCK BIPOLAR HEAD.
Among these devices, 7 are declared sterile, 7 implantable, 4 reusable.
Devices declared under this manufacturer
- DELTA CUP - 20°ANGLED SPACER #L+5 USE LINER #MEDIUM
- DELTA-ONE-TT CUP - ACETABULAR CUP DIA.56 MM (LINER #LARGE)
- LOCK BIPOLAR HEAD - LINER DIA.44 MM FOR HEADS 28 MM
- MULTIGEN PLUS - H TIBIAL AUGMENT #4 - H.7 MM
- ProMade Elbow - Drilling Guide for Dia.3.2mm Drill
- ProMade Elbow - Trial Screw for Humeral Epicondyles
- ProMade Shoulder - Altivate Trial Safety Screw
- ProMade Shoulder - Drilling Guide for Prima Locking Screws
- REVISION HIP - UNCEMENTED STEM D.16 MM L.140 MM
- REVISION HIP - UNCEMENTED STEM D.20 MM L.200 MM
- SMR SHOULDER - FINNED STEM - SHORT DIA.17 MM
Catalogue references include 1304.15.017, 3812.15.010, 3816.15.020, 5527.05.440, 5549.14.560, 5886.15.520.
European nomenclature codes declared: L0922, P090804030202, V06010103, P090803010201,P0908030302, P090805, P0901040202.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Limacorporate S.p.A. (IT) · FDA 3008395353 |
| Devices in EUDAMED | 11 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 11 |
|---|---|
| Found in the U.S. device database | 3 |
| Share | 27.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | LIMACORPORATE S.P.A. |
What it holds in Canada
| Licences on record | 7 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| Class 3 devices | 5 |
| First licensed | 2014-05-01 |
Licence types: System (6), Device Group (1).
Licensed under: SMR SHOULDER SYSTEM, SMR SHOULDER GLENOID BONE GRAFT INSTRUMENT SET, SMR TT HYBRID GLENOID, SMR STEMLESS, SMR INSTRUMENT SYSTEM, SMR TT AUGMENTED 360 BASEPLATE.
North American profile: Both markets. LIMACORPORATE S.p.A. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G13 075731 0072 | reissued | 2030-05-21 |
G12 075731 0076 | supplemented | 2027-10-16 |
G11 075731 0074 | reissued | 2030-05-21 |
G10 075731 0077 | restricted | 2027-10-23 |
018-00-09-MDR | supplemented | 2028-05-03 |