K200523 is an FDA 510(k) clearance for the Biolign® Roto-Loc Cervical Plate System. This device is classified as a Appliance, Fixation, Spinal Intervertebral Body (Class II - Special Controls, product code KWQ).
Submitted by Elite Surgical Supplies (Pty), Ltd. (Pretoria, ZA). The FDA issued a Cleared decision on April 30, 2020, 59 days after receiving the submission on March 2, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K200523 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2020 |
| Decision Date | April 30, 2020 |
| Days to Decision | 59 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 |