Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K213301
InCore Subtalar System · Nextremity Solutions, Inc. · decided 2021-12-21 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| InCore Subtalar | ICSUBCFL | Medartis Inc. | LXH | 00817701028826 |
| InCore Subtalar | ICSUB56DB | Medartis Inc. | LXH | 00817701028703 |
| InCore Subtalar | ICSUBTLH | Medartis Inc. | LXH | 00817701028758 |
| InCore Subtalar | ICSUBPGL | Medartis Inc. | LXH | 00817701028628 |
| InCore Subtalar | ICSUBPGR | Medartis Inc. | LXH | 00817701028611 |
| InCore Subtalar | ICSUBCASE | Medartis Inc. | LXH | 00817701028765 |
| InCore Subtalar | ICSUBCFR | Medartis Inc. | LXH | 00817701028819 |
| InCore Subtalar | ICSUBTGL | Medartis Inc. | HWC | 00817701028642 |
| InCore Subtalar | ICSUBTGR | Medartis Inc. | HWC | 00817701028635 |
| InCore Subtalar | ICSUB56DBD | Medartis Inc. | LXH | 00817701028802 |
| InCore Subtalar | ICSUBLID | Medartis Inc. | LXH | 00817701028772 |
| InCore Subtalar | ICSUBDP | Medartis Inc. | LXH | 00817701028741 |