K143279 is an FDA 510(k) clearance for the LnK Anterior Cervical Plate System. This device is classified as a Appliance, Fixation, Spinal Intervertebral Body (Class II - Special Controls, product code KWQ).
Submitted by L & K Biomed Co., Ltd. (Giheung-Gu, Yongin-Si, KR). The FDA issued a Cleared decision on March 20, 2015, 126 days after receiving the submission on November 14, 2014.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K143279 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2014 |
| Decision Date | March 20, 2015 |
| Days to Decision | 126 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWQ — Appliance, Fixation, Spinal Intervertebral Body |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |