K081978 is an FDA 510(k) clearance for the RELIANCE SPINAL SCREW SYSTEM. This device is classified as a Orthosis, Spinal Pedicle Fixation (Class II - Special Controls, product code MNI).
Submitted by Reliance Medical Systems, LLC (Sandy, US). The FDA issued a Cleared decision on March 26, 2009, 258 days after receiving the submission on July 11, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070.
| 510(k) Number | K081978 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2008 |
| Decision Date | March 26, 2009 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MNI — Orthosis, Spinal Pedicle Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |