K142114 is an FDA 510(k) clearance for the Xia® Growth Rod Conversion Set. This device is classified as a Growing Rod System (Class II - Special Controls, product code PGM).
Submitted by Stryker Corporation (Allendale, US). The FDA issued a Cleared decision on October 27, 2014, 84 days after receiving the submission on August 4, 2014.
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 | K142114 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2014 |
| Decision Date | October 27, 2014 |
| Days to Decision | 84 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. |