Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K172185
Tyber Medical PT Interbody Spacer System · Tyber Medical, LLC · decided 2017-12-21 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ACIS® ProTi 360°™ | 108843110 | Tyber Medical, LLC | ODP | 00819917020052 |
| CONCORDE® ProTi 360°™ | 188827415 | Tyber Medical, LLC | MAX | 00819917021356 |
| CONCORDE® ProTi 360°™ | 188827105 | Tyber Medical, LLC | MAX | 00819917021080 |
| ACIS® ProTi 360°™ | 108843007 | Tyber Medical, LLC | ODP | 00819917020427 |
| CONCORDE® ProTi 360°™ | 188823114 | Tyber Medical, LLC | MAX | 00819917020816 |
| ACIS® ProTi 360°™ | 108843009 | Tyber Medical, LLC | ODP | 00819917020441 |
| ACIS® ProTi 360°™ | 108843108 | Tyber Medical, LLC | ODP | 00819917020038 |
| CONCORDE® ProTi 360°™ | 188827115 | Tyber Medical, LLC | MAX | 00819917021189 |
| CONCORDE® ProTi 360°™ | 188827410 | Tyber Medical, LLC | MAX | 00819917021301 |
| ACIS® ProTi 360°™ | 108843509 | Tyber Medical, LLC | ODP | 00819917020601 |
| ACIS® ProTi 360°™ | 108843810 | Tyber Medical, LLC | ODP | 00819917020373 |
| ACIS® ProTi 360°™ | 108843706 | Tyber Medical, LLC | ODP | 00819917020250 |
| ACIS® ProTi 360°™ | 108843209 | Tyber Medical, LLC | ODP | 00819917020120 |
| CONCORDE® ProTi 360°™ | 188831211 | Tyber Medical, LLC | MAX | 00819917021486 |
| ACIS® ProTi 360°™ | 108843505 | Tyber Medical, LLC | ODP | 00819917020564 |
| CONCORDE® ProTi 360°™ | 188835213 | Tyber Medical, LLC | MAX | 00819917021592 |
| CONCORDE® ProTi 360°™ | 188827211 | Tyber Medical, LLC | MAX | 00819917021233 |
| ACIS® ProTi 360°™ | 108843112 | Tyber Medical, LLC | ODP | 00819917020076 |
| CONCORDE® ProTi 360°™ | 188827207 | Tyber Medical, LLC | MAX | 00819917021196 |
| CONCORDE® ProTi 360°™ | 188827106 | Tyber Medical, LLC | MAX | 00819917021097 |
| CONCORDE® ProTi 360°™ | 188823210 | Tyber Medical, LLC | MAX | 00819917020861 |
| ACIS® ProTi 360°™ | 108843011 | Tyber Medical, LLC | ODP | 00819917020465 |
| ACIS® ProTi 360°™ | 108843010 | Tyber Medical, LLC | ODP | 00819917020458 |
| CONCORDE® ProTi 360°™ | 188835208 | Tyber Medical, LLC | MAX | 00819917021547 |
| ACIS® ProTi 360°™ | 108843511 | Tyber Medical, LLC | ODP | 00819917020625 |