K191212 is an FDA 510(k) clearance for the CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System. This device is classified as a Growing Rod System (Class II - Special Controls, product code PGM).
Submitted by Medos International SARL (Lelocle, CH). The FDA issued a Cleared decision on September 24, 2019, 141 days after receiving the submission on May 6, 2019.
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 | K191212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2019 |
| Decision Date | September 24, 2019 |
| Days to Decision | 141 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. |