Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K152277
PIVOX(tm) Oblique Lateral Spinal System · Medtronic Sofamor Danek USA, Inc. · decided 2015-11-13 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| PIVOX™ Oblique Lateral Spinal System | 2131360 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169605022 |
| PIVOX™ Oblique Lateral Spinal System | 2131240 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169604933 |
| PIVOX™ Oblique Lateral Spinal System | 2190240 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169598935 |
| PIVOX™ Oblique Lateral Spinal System | 2110260 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169601239 |
| PIVOX™ Oblique Lateral Spinal System | 2172355 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169595439 |
| PIVOX™ Oblique Lateral Spinal System | 2172245 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169595408 |
| PIVOX™ Oblique Lateral Spinal System | 2130540 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169604889 |
| PIVOX™ Oblique Lateral Spinal System | 2130350 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169604803 |
| PIVOX™ Oblique Lateral Spinal System | 2173360 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169600041 |
| PIVOX™ Oblique Lateral Spinal System | 2191350 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169599178 |
| PIVOX™ Oblique Lateral Spinal System | 2190455 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169599062 |
| PIVOX™ Oblique Lateral Spinal System | 2122640 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169606470 |
| PIVOX™ Oblique Lateral Spinal System | 2111445 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169601550 |
| PIVOX™ Oblique Lateral Spinal System | 2173560 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169600140 |
| PIVOX™ Oblique Lateral Spinal System | 2173540 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169600102 |
| PIVOX™ Oblique Lateral Spinal System | 2172640 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169596184 |
| PIVOX™ Oblique Lateral Spinal System | 2172655 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00763000878467 |
| PIVOX™ Oblique Lateral Spinal System | 2140020 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169639553 |
| PIVOX™ Oblique Lateral Spinal System | 2190540 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169599086 |
| PIVOX™ Oblique Lateral Spinal System | 2191245 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169595507 |
| PIVOX™ Oblique Lateral Spinal System | 2171440 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169596009 |
| PIVOX™ Oblique Lateral Spinal System | 2172445 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00763000878412 |
| PIVOX™ Oblique Lateral Spinal System | 2143001 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169639577 |
| PIVOX™ Oblique Lateral Spinal System | 2191455 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00643169595552 |
| PIVOX™ Oblique Lateral Spinal System | 2173455 | MEDTRONIC SOFAMOR DANEK, INC. | KWQ MAX OVD | 00763000878504 |