K201029 is an FDA 510(k) clearance for the Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System. This device is classified as a Appliance, Fixation, Spinal Intervertebral Body (Class II - Special Controls, product code KWQ).
Submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 17, 2020, 58 days after receiving the submission on April 20, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K201029 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 2020 |
| Decision Date | June 17, 2020 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| 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 |