The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Aleutian Spacer System.
| Device ID | K063399 |
| 510k Number | K063399 |
| Device Name: | ALEUTIAN SPACER SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Contact | Rich Woods |
| Correspondent | Rich Woods K2M, INC. 751 MILLER DR.,SE 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 | 2006-11-09 |
| Decision Date | 2007-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857126190 | K063399 | 000 |
| 10888857121386 | K063399 | 000 |