K063399 is an FDA 510(k) clearance for the ALEUTIAN SPACER SYSTEM. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).
Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on February 23, 2007, 106 days after receiving the submission on November 9, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K063399 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2006 |
| Decision Date | February 23, 2007 |
| Days to Decision | 106 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 |