K173787 is an FDA 510(k) clearance for the X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).
Submitted by Medos International SARL (Lelocle, CH). The FDA issued a Cleared decision on June 11, 2018, 179 days after receiving the submission on December 14, 2017.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K173787 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2017 |
| Decision Date | June 11, 2018 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MQP — Spinal Vertebral Body Replacement Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |