K150200 is an FDA 510(k) clearance for the CD HORIZON Growth Rod Conversion Set. This device is classified as a Growing Rod System (Class II - Special Controls, product code PGM).
Submitted by Medtronic Sofamor Danek USA, Incorporated (Memphis, US). The FDA issued a Cleared decision on February 25, 2015, 27 days after receiving the submission on January 29, 2015.
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 | K150200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 2015 |
| Decision Date | February 25, 2015 |
| Days to Decision | 27 days |
| Submission Type | Special |
| 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. |