K161028 is an FDA 510(k) clearance for the K2M Growing Spine System. This device is classified as a Growing Rod System (Class II - Special Controls, product code PGM).
Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on July 22, 2016, 101 days after receiving the submission on April 12, 2016.
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 | K161028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2016 |
| Decision Date | July 22, 2016 |
| Days to Decision | 101 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. |