Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K110598
SMR REVERSE SHOULDER SYSTEM · Lima Corporate S.P.A. · decided 2011-08-18 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SMR System | 1374.09.105 | LIMACORPORATE SPA | KWS PHX | 08033390272216 |
| SMR Shoulder | Long Stem for Glenosphere Extractor | LIMACORPORATE SPA | KWS | 08033390120784 |
| SMR System | 1361.50.815 | LIMACORPORATE SPA | KWS PHX | 08033390273633 |
| SMR Shoulder | Connector + Screw | LIMACORPORATE SPA | KWS | 08033390002349 |
| SMR Shoulder | Trial Liner | LIMACORPORATE SPA | KWS | 08033390098915 |
| SMR Shoulder | Trial Retentive Liner | LIMACORPORATE SPA | KWS | 08033390065214 |
| SMR Shoulder | Bone Graft Reamer | LIMACORPORATE SPA | KWS | 08033390091671 |
| SMR Shoulder | Trial Extension for Reverse Humeral Body | LIMACORPORATE SPA | KWS | 08033390039697 |
| SMR Shoulder | Conical Reamer | LIMACORPORATE SPA | KWS | 08033390023405 |
| SMR System | 1352.15.005 | LIMACORPORATE SPA | KWS PHX | 08033390272551 |
| SMR System | 1352.15.050 | LIMACORPORATE SPA | KWS PHX | 08033390272575 |
| SMR SYSTEM | 9CC0.95.097 | LIMACORPORATE SPA | KWS | 08033390195300 |
| Guide Screw for Trial Glenosphere | Guide Screw | LIMACORPORATE SPA | KWS | 08033390113793 |
| SMR Shoulder | Liner | LIMACORPORATE SPA | KWS | 08033390080613 |
| SMR Shoulder | Trial Liner | LIMACORPORATE SPA | KWS | 08033390039048 |
| SMR Shoulder | 9013.52.024 | LIMACORPORATE SPA | KWS | 08033390152037 |
| SMR System | 1352.15.010 | LIMACORPORATE SPA | KWS PHX | 08033390272568 |
| SMR Shoulder | Guide for Conical Reamer | LIMACORPORATE SPA | KWS | 08033390122108 |
| SMR Shoulder | Glenosphere Orienter | LIMACORPORATE SPA | KWS | 08033390099042 |
| SMR Metal Back | Uncemented Glenoid | LIMACORPORATE SPA | KWS | 08033390071741 |
| SMR Shoulder | Reverse Resection Jig - LA | LIMACORPORATE SPA | KWS | 08033390098380 |
| SMR Shoulder | 9013.52.014 | LIMACORPORATE SPA | KWS | 08033390152020 |
| SMR Shoulder | 9013.52.129 | LIMACORPORATE SPA | KWS | 08033390152051 |
| SMR SHOULDER | Trial Glenosphere | LIMACORPORATE SPA | KWS | 08033390109963 |
| SMR Shoulder | Trial Reverse Humeral Body | LIMACORPORATE SPA | KWS | 08033390100113 |