K143278 is an FDA 510(k) clearance for the LnK Posterior Cervical Fixation System. This device is classified as a Appliance, Fixation, Spinal Interlaminal (Class II - Special Controls, product code KWP).
Submitted by L & K Biomed Co., Ltd. (Giheung-Gu, Yongin-Si, KR). The FDA issued a Cleared decision on July 29, 2015, 257 days after receiving the submission on November 14, 2014.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3050.
| 510(k) Number | K143278 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2014 |
| Decision Date | July 29, 2015 |
| Days to Decision | 257 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWP — Appliance, Fixation, Spinal Interlaminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3050 |