Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K172092
Reprocessed Shavers/Burs · Renovo, Inc. · decided 2017-10-04 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Arthrex | AR-8500SR | Provision | HRX | 00810041062895 |
| Arthrex | AR-6420ST | Provision | HRX | B504ASAR6420ST0 |
| Smith & Nephew | 7205324 | Provision | HRX | B504AB72053240 |
| Stryker | 485-860-000 | Provision | HRX | B504AB4858600000 |
| Stryker | 385-552-000 | Provision | HRX | 00810041636188 |
| Arthrex | AR-8400HSO | Provision | HRX | 00810041062840 |
| Smith & Nephew | 7209335 | Provision | HRX | B504AB72093350 |
| Conmed Linvatec | 42CUD-RA-ZZ | Provision | HRX | B50442CUDRAZZ0 |
| ConMed | SC9248 | Provision | HRX | B504ASSC92480 |
| Conmed Linvatec | EL9247U | Provision | HRX | B504ASEL9247U0 |
| Smith and Nephew | 72201513 | Provision | HRX | B504AS722015130 |
| Sustainable Technologies | ST375-950-000 | Provision | HRX | 00810041636034 |
| Sustainable Technologies | ST375-940-012 | Provision | HRX | 00810041635976 |
| Sustainable Technologies | ST375-636-000 | Provision | HRX | 00810041635853 |
| Smith and Nephew | 7205319 | Provision | HRX | 00810041631817 |
| Conmed/Linvatec | C9990 | Provision | HRX | 00810041067548 |
| Sustainable Technologies | ST9399A | Provision | HRX | 00810041066718 |
| Stryker | 375-555-000 | Provision | HRX | B504AS3755550000 |
| DePuy Mitek | 283209 | Provision | HRX | B504AS2832090 |
| Conmed Linvatec | H9118 | Provision | HRX | B504ABH91180 |
| Arthrex | AR-8500FOE | Provision | HRX | B504ABAR8500FOE0 |
| DePuy Mitek | 283878 | Provision | HRX | B504AB2838780 |
| Smith and Nephew | 7205318 | Provision | HRX | 00810041631800 |
| Smith and Nephew | 7205341 | Provision | HRX | 00810041060686 |
| Conmed Linvatec | MH9112 | Provision | HRX | B504ABMH91120 |