K040284 is an FDA 510(k) clearance for the SUSTAIN RADIOLUCENT SPACER. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).
Submitted by Globus Medical, Inc. (Phoenixville, US). The FDA issued a Cleared decision on March 23, 2004, 46 days after receiving the submission on February 6, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K040284 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2004 |
| Decision Date | March 23, 2004 |
| Days to Decision | 46 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MQP — Spinal Vertebral Body Replacement Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |