K181068 is an FDA 510(k) clearance for the CREO® Stabilization System, REVERE® Stabilization System. This device is classified as a Growing Rod System (Class II - Special Controls, product code PGM).
Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on June 29, 2018, 67 days after receiving the submission on April 23, 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 | K181068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2018 |
| Decision Date | June 29, 2018 |
| Days to Decision | 67 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. |