K213196 is an FDA 510(k) clearance for the MARVEL™ Growing Rods. This device is classified as a Growing Rod System (Class II - Special Controls, product code PGM).
Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on December 19, 2022, 446 days after receiving the submission on September 29, 2021.
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 | K213196 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2021 |
| Decision Date | December 19, 2022 |
| Days to Decision | 446 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. |