K123093 is an FDA 510(k) clearance for the STABILINK MIS SPINAL FIXATION SYSTEM. This device is classified as a Appliance, Fixation, Spinal Interlaminal (Class II - Special Controls, product code KWP).
Submitted by Southern Spine, LLC (Alpharetta, US). The FDA issued a Cleared decision on December 20, 2012, 79 days after receiving the submission on October 2, 2012.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3050.
| 510(k) Number | K123093 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2012 |
| Decision Date | December 20, 2012 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| 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 |