K193224 is an FDA 510(k) clearance for the Daytona® Small Stature Growth Rod Conversion Set. This device is classified as a Growing Rod System (Class II - Special Controls, product code PGM).
Submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on February 13, 2020, 83 days after receiving the submission on November 22, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070. Stabilization Or Correction Of Spinal Deformities Without The Use Of Fusion..
| 510(k) Number | K193224 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2019 |
| Decision Date | February 13, 2020 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PGM — Growing Rod System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |
| Definition | Stabilization Or Correction Of Spinal Deformities Without The Use Of Fusion. |