Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K163397
SMR Hybrid Glenoid System · Lima Corporate S.P.A. · decided 2017-06-29 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SMR Shoulder | 1379.59.302 | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390267540 |
| SMR Shoulder - Hybrid Glenoid | Trial Glenoid | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390121262 |
| SMR Shoulder | 1379.59.304 | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390267564 |
| SMR Shoulder | Glenosphere | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390123129 |
| SMR TT Hybrid Glenoid | 1379.59.232 | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390121866 |
| SMR Shoulder | 1379.59.210 | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390267151 |
| SMR Shoulder | 1379.59.102 | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390266796 |
| SMR Shoulder | 1379.59.103 | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390266802 |
| SMR Shoulder | 1379.59.212 | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390267175 |
| SMR Shoulder | 1379.59.114 | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390266918 |
| SMR Shoulder - Hybrid Glenoid | K-Wire Positioning Jig | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390124256 |
| SMR Shoulder - Hybrid Glenoid | Baseplate Extractor | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390124232 |
| SMR Shoulder - Hybrid Glenoid | Trial Glenoid | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390121255 |
| SMR TT Hybrid Glenoid | 1379.59.133 | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390121637 |
| SMR TT Hybrid Glenoid | 1379.59.134 | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390121644 |
| SMR TT Hybrid Glenoid | 1379.59.111 | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390121569 |
| SMR Shoulder - Hybrid Glenoid | Trial Glenoid | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390121170 |
| SMR Shoulder - Hybrid Glenoid | Glenoid Positioner | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390121415 |
| SMR Shoulder | 1379.59.234 | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390267519 |
| SMR Shoulder - Hybrid Glenoid | Glenosphere Extraction Insert | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390124188 |
| SMR TT Hybrid Glenoid | 1379.59.100 | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390121002 |
| SMR System | 1376.09.031 | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390272339 |
| SMR Shoulder | 1379.59.221 | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390267229 |
| SMR Shoulder - Hybrid Glenoid | Glenosphere Insertion Guide | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390124201 |
| SMR TT Hybrid Glenoid | 1379.59.321 | LIMACORPORATE SPA | KWS KWT MBF PHX | 08033390121927 |