K142867 is an FDA 510(k) clearance for the Reliance Posterior Cervical-Thoracic System. This device is classified as a Appliance, Fixation, Spinal Interlaminal (Class II - Special Controls, product code KWP).
Submitted by Reliance Medical Systems, LLC (Bountiful, US). The FDA issued a Cleared decision on April 29, 2015, 210 days after receiving the submission on October 1, 2014.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3050.
| 510(k) Number | K142867 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2014 |
| Decision Date | April 29, 2015 |
| Days to Decision | 210 days |
| Submission Type | Special |
| 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 |