K080024 is an FDA 510(k) clearance for the ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01. 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 January 24, 2008, 20 days after receiving the submission on January 4, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K080024 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 04, 2008 |
| Decision Date | January 24, 2008 |
| Days to Decision | 20 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 |