K172979 is an FDA 510(k) clearance for the NuVasive® Growth Rod Conversion Set. This device is classified as a Growing Rod System (Class II - Special Controls, product code PGM).
Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on November 6, 2017, 40 days after receiving the submission on September 27, 2017.
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 | K172979 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2017 |
| Decision Date | November 06, 2017 |
| Days to Decision | 40 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. |