Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K100858
LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES, · Lima-Lto S.P.A. · decided 2010-12-10 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SMR Shoulder | Impactor Guide | LIMACORPORATE SPA | HSD KWT | 08033390095440 |
| SMR Shoulder | Stem Impactor | LIMACORPORATE SPA | HSD KWT | 08033390038300 |
| SMR Shoulder | Conical Trial Stem | LIMACORPORATE SPA | HSD KWT | 08033390038225 |
| SMR Shoulder | Eccentrical Adaptor | LIMACORPORATE SPA | HSD KWT | 08033390001984 |
| SMR Shoulder | Reverse Adaptor Sleeve | LIMACORPORATE SPA | HSD KWT | 08033390100205 |
| SMR Shoulder | Humeral Reamer | LIMACORPORATE SPA | HSD KWT | 08033390084314 |
| SMR Shoulder | Trial Adaptor | LIMACORPORATE SPA | HSD KWT | 08033390038874 |
| SMR Shoulder | Inserter-Extractor Handle | LIMACORPORATE SPA | HSD KWT | 08033390122221 |
| SMR Shoulder | Threaded Extractor | LIMACORPORATE SPA | HSD KWT | 08033390097574 |
| SMR Shoulder | Humeral Head | LIMACORPORATE SPA | HSD KWT | 08033390001403 |
| SMR Shoulder | Pushrod Tip for Reverse | LIMACORPORATE SPA | HSD KWT | 08033390104227 |
| SMR Shoulder | Glenoid Drill | LIMACORPORATE SPA | HSD KWT | 08033390097611 |
| ProMade | 9CC0.13.004 | LIMACORPORATE SPA | HSD KWT | 08033390116657 |
| SMR Shoulder | Trial Humeral Head | LIMACORPORATE SPA | HSD KWT | 08033390038492 |
| SMR | Extractor for Anatomic Trial Body | LIMACORPORATE SPA | HSD KWT | 08033390120593 |
| SMR Shoulder | Conical Trial Stem | LIMACORPORATE SPA | HSD KWT | 08033390022965 |
| SMR Shoulder | Eccentrical Adaptor | LIMACORPORATE SPA | HSD KWT | 08033390001960 |
| SMR Shoulder | Cemented Stem | LIMACORPORATE SPA | HSD KWT | 08033390001007 |
| SMR System | 1306.15.200 | LIMACORPORATE SPA | KWT | 08033390271011 |
| SMR Shoulder | Pushrod Tip | LIMACORPORATE SPA | HSD KWT | 08033390100083 |
| SMR Shoulder system | 9CC0.13.029 | LIMACORPORATE SPA | HSD KWT | 08033390147989 |
| SMR Shoulder | Impactor Guide | LIMACORPORATE SPA | HSD KWT | 08033390122382 |
| Cannulated Humeral Head Impactor | Humeral Head Impactor | LIMACORPORATE SPA | HSD KWT | 08033390104685 |
| SMR System | 1322.09.500 | LIMACORPORATE SPA | HSD KWT | 08033390274272 |
| TRIAL HUMERAL HEAD ECCENTRICITY | TRIAL HUMERAL HEAD | LIMACORPORATE SPA | HSD KWT | 08033390105316 |