Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| GDLH® Posterior Spinal System | X0196-107 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH | 00673978130347 |
| GDLH® Posterior Spinal System | X0196-122 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH | 00721902975189 |
| GDLH® Posterior Spinal System | X0196-118 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH | 00673978130415 |
| GDLH® Posterior Spinal System | X0196-128 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH | 00721902975226 |
| GDLH® Posterior Spinal System | X0196-104 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH | 00673978130316 |
| GDLH® Posterior Spinal System | X0196-111 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH | 00721902975158 |
| CD HORIZON® Spinal System | X0200027 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH | 00673978995168 |
| GDLH® Posterior Spinal System | X0196-126 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH | 00721902975219 |
| GDLH® Posterior Spinal System | X0196-130 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH | 00721902975233 |
| GDLH® Posterior Spinal System | 855-011 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH | 00673978061825 |
| GDLH® Posterior Spinal System | X0196-116 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH | 00673978130408 |
| GDLH® Posterior Spinal System | X0196-114 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH | 00673978130392 |
| GDLH® Posterior Spinal System | X0196-109 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH | 00673978130361 |
| GDLH® Posterior Spinal System | X0196-120 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH | 00673978130422 |