The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Aleutian Spacer, Model K2-07-1004-01, K2-07-1005-01.
| Device ID | K080024 |
| 510k Number | K080024 |
| Device Name: | ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01 |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | K2M, INC. 751 MILLER DR. SE, SUITE F1 Leesburg, VA 20175 |
| Contact | Richard W Woods |
| Correspondent | Richard W Woods K2M, INC. 751 MILLER DR. SE, SUITE F1 Leesburg, VA 20175 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-04 |
| Decision Date | 2008-01-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857134225 | K080024 | 000 |
| 10888857131040 | K080024 | 000 |
| 10888857131446 | K080024 | 000 |
| 10888857131460 | K080024 | 000 |
| 10888857131965 | K080024 | 000 |
| 10888857131989 | K080024 | 000 |
| 10888857132504 | K080024 | 000 |
| 10888857132528 | K080024 | 000 |
| 10888857133068 | K080024 | 000 |
| 10888857133082 | K080024 | 000 |
| 10888857133631 | K080024 | 000 |
| 10888857133655 | K080024 | 000 |
| 10888857134201 | K080024 | 000 |
| 10888857131033 | K080024 | 000 |