Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K103731
CAPSTONE R SPINAL SYSTEM · Medtronic Sofamor Danek · decided 2011-07-18 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| (unnamed) | X1117023 | MEDTRONIC SOFAMOR DANEK, INC. | MAX MQP | 00763000096885 |
| (unnamed) | X1117015 | MEDTRONIC SOFAMOR DANEK, INC. | MAX MQP | 00763000096892 |
| (unnamed) | X1117017 | MEDTRONIC SOFAMOR DANEK, INC. | MAX MQP | 00763000096915 |
| (unnamed) | X1117016 | MEDTRONIC SOFAMOR DANEK, INC. | MAX MQP | 00763000096908 |
| (unnamed) | X1117022 | MEDTRONIC SOFAMOR DANEK, INC. | MAX MQP | 00763000096878 |
| Medtronic Reusable Instruments | 2990001 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00613994803061 |
| Reprocessing Instructions for the Capstone Inserter | 2990003 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00613994846266 |