Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K172115
Navigated Instrument System · Orthofix, Inc. · decided 2018-03-08 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1350 | Orthofix US LLC | OLO | 18257200119820 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1326 | Orthofix US LLC | OLO | 18257200119523 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1339 | Orthofix US LLC | OLO | 18257200119387 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1317 | Orthofix US LLC | OLO | 18257200119295 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1314 | Orthofix US LLC | OLO | 18257200119264 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1329 | Orthofix US LLC | OLO | 18257200119653 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1324 | Orthofix US LLC | OLO | 18257200119509 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1319 | Orthofix US LLC | OLO | 18257200119417 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1340 | Orthofix US LLC | OLO | 18257200119554 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1338 | Orthofix US LLC | OLO | 18257200119622 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1316 | Orthofix US LLC | OLO | 18257200119288 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1313 | Orthofix US LLC | OLO | 18257200119400 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1335 | Orthofix US LLC | OLO | 18257200119592 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1351 | Orthofix US LLC | OLO | 18257200121809 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1352 | Orthofix US LLC | OLO | 18257200121816 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1345 | Orthofix US LLC | OLO | 18257200119325 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1315 | Orthofix US LLC | OLO | 18257200119271 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1336 | Orthofix US LLC | OLO | 18257200119608 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1318 | Orthofix US LLC | OLO | 18257200119301 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1311 | Orthofix US LLC | OLO | 18257200119257 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1346 | Orthofix US LLC | OLO | 18257200119332 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1333 | Orthofix US LLC | OLO | 18257200119370 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1322 | Orthofix US LLC | OLO | 18257200119639 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1320 | Orthofix US LLC | OLO | 18257200119486 |
| NAVIGATED INSTRUMENTS;FIREBIRD NXG | 36-1310 | Orthofix US LLC | OLO | 18257200119240 |