Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K102670
TOTAL SHOULDER SYSTEM · Shoulder Innovations, LLC · decided 2011-01-24 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Shoulder Innovations Humeral Short Stem System | 21mm x 44mm | Shoulder Innovations, Inc. | HSD KWS KWT MBF | B1132N2HE210441 |
| Shoulder Innovations InSet 95 Humeral Stem | 15mm Stem Broach | Shoulder Innovations, Inc. | HSD KWS KWT MBF | B1132L2HB000150 |
| Shoulder Innovations TSA | Flat Humeral Sizer, Size 52mm | Shoulder Innovations, Inc. | HSD KWS KWT LXH MBF | B1132N1HS000520 |
| Shoulder Innovations TSA | 20 mm x 5° | Shoulder Innovations, Inc. | HSD KWS KWT | B1132N1AC20005 |
| Shoulder Innovations Humeral Short Stem System | 48mm Open Norris Ring | Shoulder Innovations, Inc. | HSD KWS KWT MBF | B1132N1IN100480 |
| Shoulder Innovations Humeral Short Stem System | Humeral Head Impactor | Shoulder Innovations, Inc. | HSD KWS KWT MBF | B1132N1IH000000 |
| Shoulder Innovations Humeral Short Stem System | 18mm x 48mm | Shoulder Innovations, Inc. | HSD KWS KWT MBF | B1132N1HE180480 |
| Shoulder Innovations TSA | 22 mm x 8 mm | Shoulder Innovations, Inc. | HSD KWS KWT | B1130S0CI220080 |
| Shoulder Innovations Humeral Short Stem System | Humeral Cut Protector - 56mm | Shoulder Innovations, Inc. | HSD KWS KWT MBF | B1132N1IP000560 |
| Shoulder Innovations IM Cut Guide | IM Cut Guide T-Handle | Shoulder Innovations, Inc. | HSD KWS KWT LXH MBF | B1132R2HC000010 |
| Shoulder Innovations Humeral Short Stem System | 44mm x 6mm | Shoulder Innovations, Inc. | HSD KWS KWT MBF | B1132N2SN064400 |
| Shoulder Innovations TSA | Flat Humeral Sizer, Size 46mm | Shoulder Innovations, Inc. | HSD KWS KWT LXH MBF | B1132N1HS000460 |
| Shoulder Innovations Humeral Short Stem System | 18 mm x 52mm | Shoulder Innovations, Inc. | HSD KWS KWT MBF | B1132N1HE180520 |
| Shoulder Innovations InSet 95 Humeral Stem | 14x95mm | Shoulder Innovations, Inc. | HSD KWS KWT MBF | B1132L1S1400010 |
| Shoulder Innovations InSet 95 Humeral Stem | 4x95mm | Shoulder Innovations, Inc. | HSD KWS KWT MBF | B1132L1S0400010 |
| Shoulder Innovations Humeral Short Stem System | 18mm x 48mm | Shoulder Innovations, Inc. | HSD KWS KWT MBF | B1132N2HE180481 |
| Shoulder Innovations Humeral Short Stem System | Screwdriver | Shoulder Innovations, Inc. | HSD KWS KWT MBF | B1132N1IS000010 |
| Shoulder Innovations Humeral Short Stem System | 15mm x 52mm | Shoulder Innovations, Inc. | HSD KWS KWT MBF | B1132N1HE150520 |
| Shoulder Innovations Humeral Short Stem System | 15mm x 40mm | Shoulder Innovations, Inc. | HSD KWS KWT MBF | B1132N1HE150400 |
| Shoulder Innovations InSet 95 Humeral Stem | 14mm Reamer Sounder | Shoulder Innovations, Inc. | HSD KWS KWT MBF | B1132L2HS000140 |
| Shoulder Innovations InSet 95 Humeral Stem | 4mm Stem Broach | Shoulder Innovations, Inc. | HSD KWS KWT MBF | B1132L2HB000040 |
| Shoulder Innovations InSet 95 Humeral Stem | 13mm Stem Broach | Shoulder Innovations, Inc. | HSD KWS KWT MBF | B1132L2HB000130 |
| Shoulder Innovations InSet 95 Humeral Stem | 10x95mm | Shoulder Innovations, Inc. | HSD KWS KWT MBF | B1132L1S1000010 |
| Shoulder Innovations Humeral Short Stem System | K-Wire Guide | Shoulder Innovations, Inc. | HSD KWS KWT MBF | B1130S1GK000020 |
| Shoulder Innovations TSA | 30 mm x 10° | Shoulder Innovations, Inc. | HSD KWS KWT | B1132N2AI300100 |