K162801 is an FDA 510(k) clearance for the CastleLoc Spinal Fixation System. This device is classified as a Orthosis, Spondylolisthesis Spinal Fixation (Class II - Special Controls, product code MNH).
Submitted by L & K Biomed Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on November 3, 2016, 29 days after receiving the submission on October 5, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070.
| 510(k) Number | K162801 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 2016 |
| Decision Date | November 03, 2016 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MNH — Orthosis, Spondylolisthesis Spinal Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |