The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Aleutian System.
| Device ID | K113138 |
| 510k Number | K113138 |
| Device Name: | ALEUTIAN SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Product Code | MAX |
| Subsequent Product Code | MQP |
| Subsequent Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-25 |
| Decision Date | 2012-01-10 |
| Summary: | summary |