K180227 is an FDA 510(k) clearance for the Polaris Spinal Growth System. This device is classified as a Growing Rod System (Class II - Special Controls, product code PGM).
Submitted by Zimmer Biomet Spine, Inc. (Westminister, US). The FDA issued a Cleared decision on March 15, 2018, 48 days after receiving the submission on January 26, 2018.
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 | K180227 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 2018 |
| Decision Date | March 15, 2018 |
| Days to Decision | 48 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. |