K133904 is an FDA 510(k) clearance for the CD HORIZON SPINAL SYSTEM GROWTH ROD SET. This device is classified as a Growing Rod System (Class II - Special Controls, product code PGM).
Submitted by Medtronic Sofamor Danek USA (Memphis, US). The FDA issued a Cleared decision on February 25, 2014, 67 days after receiving the submission on December 20, 2013.
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 | K133904 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2013 |
| Decision Date | February 25, 2014 |
| Days to Decision | 67 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. |