Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K200095
Streamline Navigated Instruments · Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · decided 2020-06-26 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Cortera | 1505-820750 | Xtant Medical Holdings, Inc. | OLO | 00840311233465 |
| Cortera | 1505-821150 | Xtant Medical Holdings, Inc. | OLO | 00840311233519 |
| Cortera | 1505-850750 | Xtant Medical Holdings, Inc. | OLO | 00840311234134 |
| Cortera | 1505-812950 | Xtant Medical Holdings, Inc. | OLO | 00840311234028 |
| Streamline | 02-S-FINDER-T-MDN | Xtant Medical Holdings, Inc. | OLO | 00810076560311 |
| Streamline | 02-SCREWINS-CL-MDN | Surgalign Spine Technologies, Inc. | OLO | 00810076560298 |
| Streamline | 02-S-FINDER-L-MDN | Xtant Medical Holdings, Inc. | OLO | 00810076560304 |
| Cortera | 1505-821250 | Surgalign Spine Technologies, Inc. | OLO | 00840311233526 |
| Cortera | 1505-810400 | Xtant Medical Holdings, Inc. | OLO | 00840311233250 |
| Cortera | 1505-800280 | Xtant Medical Holdings, Inc. | OLO | 00840311232536 |
| Streamline | 04-S-FINDER-MDN | Surgalign Spine Technologies, Inc. | OLO | 00810076560045 |
| Cortera | 1505-812400 | Xtant Medical Holdings, Inc. | OLO | 00840311233922 |
| Cortera | 1505-821050 | Xtant Medical Holdings, Inc. | OLO | 00840311233502 |
| Cortera | 1505-850700 | Xtant Medical Holdings, Inc. | OLO | 00840311234127 |
| Streamline | 04-CANNTAP-65-MDN | Xtant Medical Holdings, Inc. | OLO | 00810076560083 |
| Streamline | 04-CANNTAP-75-MDN | Xtant Medical Holdings, Inc. | OLO | 00810076560090 |
| Cortera | 1505-812850 | Xtant Medical Holdings, Inc. | OLO | 00840311234011 |
| Cortera | 1505-811250 | Xtant Medical Holdings, Inc. | OLO | 00840311233380 |
| Cortera | 1505-810700 | Xtant Medical Holdings, Inc. | OLO | 00840311233311 |
| Streamline | 04-CANNTAP-40-MDN | Xtant Medical Holdings, Inc. | OLO | 00810076560052 |
| Cortera | 1505-812450 | Surgalign Spine Technologies, Inc. | OLO | 00840311233939 |
| Cortera | 1505-820850 | Xtant Medical Holdings, Inc. | OLO | 00840311233489 |
| Cortera | 1505-851050 | Xtant Medical Holdings, Inc. | OLO | 00840311234172 |
| Cortera | 1505-820500 | Xtant Medical Holdings, Inc. | OLO | 00840311233410 |
| Cortera | 1505-820650 | Xtant Medical Holdings, Inc. | OLO | 00840311233441 |