K172269 is an FDA 510(k) clearance for the FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System. This device is classified as a Bone Cement, Posterior Screw Augmentation (Class II - Special Controls, product code PML).
Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on March 27, 2018, 242 days after receiving the submission on July 28, 2017.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027. The Device Is Intended To Augment The Fixation Of Screws In A Posterior Spinal System Construct..
| 510(k) Number | K172269 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2017 |
| Decision Date | March 27, 2018 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PML — Bone Cement, Posterior Screw Augmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |
| Definition | The Device Is Intended To Augment The Fixation Of Screws In A Posterior Spinal System Construct. |