Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K231839
CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System · L&K BIOMED Co., Ltd. · decided 2023-07-19 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CastleLoc-P Anterior Cervical Plate System | 6712-1731S | L&K BIOMED CO. ,LTD. | KWQ | 08800061394320 |
| AccelFix Lumbar Plate System | 5015-1426S | L&K BIOMED CO. ,LTD. | KWQ | 08800061394405 |
| AccelFix Lumbar Plate System | 5015-1527S | L&K BIOMED CO. ,LTD. | KWQ | 08800061394412 |
| CastleLoc-P Anterior Cervical Plate System | 6712-1733S | L&K BIOMED CO. ,LTD. | KWQ | 08800061394337 |
| AccelFix Lumbar Plate System | 5015-1628 | L&K BIOMED CO. ,LTD. | KWQ | 08800061394382 |
| CastleLoc-P Anterior Cervical Plate System | 6713-1742S | L&K BIOMED CO. ,LTD. | KWQ | 08800061394344 |
| AccelFix Lumbar Plate System | 5015-1426 | L&K BIOMED CO. ,LTD. | KWQ | 08800061394368 |
| AccelFix Lumbar Plate System | 5015-1527 | L&K BIOMED CO. ,LTD. | KWQ | 08800061394375 |
| CastleLoc-P Anterior Cervical Plate System | 6713-1745S | L&K BIOMED CO. ,LTD. | KWQ | 08800061394351 |
| CastleLoc-P Anterior Cervical Plate System | 6713-1745 | L&K BIOMED CO. ,LTD. | KWQ | 08800061394313 |
| CastleLoc-P Anterior Cervical Plate System | 6712-1733 | L&K BIOMED CO. ,LTD. | KWQ | 08800061394290 |
| AccelFix Lumbar Plate System | 5015-1830S | L&K BIOMED CO. ,LTD. | KWQ | 08800061394436 |
| AccelFix Lumbar Plate System | 5015-1830 | L&K BIOMED CO. ,LTD. | KWQ | 08800061394399 |
| CastleLoc-P Anterior Cervical Plate System | 6712-1731 | L&K BIOMED CO. ,LTD. | KWQ | 08800061394283 |
| AccelFix Lumbar Plate System | 5015-1628S | L&K BIOMED CO. ,LTD. | KWQ | 08800061394429 |
| CastleLoc-P Anterior Cervical Plate System | 6713-1742 | L&K BIOMED CO. ,LTD. | KWQ | 08800061394306 |