Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K112900
SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS · Lima Corporate S.P.A. · decided 2012-06-01 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SMR Shoulder | Resurfacing Head | LIMACORPORATE SPA | HSD KWS | 08033390080569 |
| SMR Resurfacing System | Gauge | LIMACORPORATE SPA | HSD KWS | 08033390038515 |
| SMR Shoulder | Resurfacing CTA Head | LIMACORPORATE SPA | HSD KWS | 08033390080590 |
| Spherical Reamer | Spherical Reamer | LIMACORPORATE SPA | HSD KWS | 08033390104708 |
| SMR Resurfacing System | Cap | LIMACORPORATE SPA | HSD KWS | 08033390038614 |
| SMR System | 1327.10.480 | LIMACORPORATE SPA | HSD KWS | 08033390271417 |
| SMR Resurfacing System | Gauge | LIMACORPORATE SPA | HSD KWS | 08033390038539 |
| SMR Resurfacing System | Trial Head | LIMACORPORATE SPA | HSD KWS | 08033390038713 |
| SMR System | 1317.15.010 | LIMACORPORATE SPA | HSD KWS | 08033390271325 |
| SMR Resurfacing System | Spherical Reamer | LIMACORPORATE SPA | HSD KWS | 08033390038645 |
| SMR System | 1328.10.460 | LIMACORPORATE SPA | HSD KWS | 08033390271806 |
| SMR System | 1327.10.460 | LIMACORPORATE SPA | HSD KWS | 08033390271400 |
| SMR System | 1328.10.500 | LIMACORPORATE SPA | HSD KWS | 08033390271820 |
| SMR Resurfacing System | Trial Head | LIMACORPORATE SPA | HSD KWS | 08033390038720 |
| SMR System | 1327.10.440 | LIMACORPORATE SPA | HSD KWS | 08033390271394 |
| SMR Resurfacing System | Trial CTA Head | LIMACORPORATE SPA | HSD KWS | 08033390038768 |
| SST Canulated Screws | Calibrated Kirschner Wire | LIMACORPORATE SPA | HSD KWS | 08033390022668 |
| SMR Resurfacing System | Gauge | LIMACORPORATE SPA | HSD KWS | 08033390038553 |
| SMR Shoulder | Resurfacing Head | LIMACORPORATE SPA | HSD KWS | 08033390080545 |
| SMR Resurfacing System | Stem Beater | LIMACORPORATE SPA | HSD KWS | 08033390038454 |
| SMR System | 1327.10.420 | LIMACORPORATE SPA | HSD KWS | 08033390271387 |
| Spherical Reamer | Spherical Reamer | LIMACORPORATE SPA | HSD KWS | 08033390104722 |
| SMR Shoulder | Resurfacing CTA Head | LIMACORPORATE SPA | HSD KWS | 08033390080576 |
| SMR Shoulder | Resurfacing Head | LIMACORPORATE SPA | HSD KWS | 08033390080538 |
| SMR Resurfacing System | Trial Head | LIMACORPORATE SPA | HSD KWS | 08033390038744 |