The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Aleutian Ibf System.
| Device ID | K101302 |
| 510k Number | K101302 |
| Device Name: | ALEUTIAN IBF SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| 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 | ODP |
| Subsequent Product Code | MAX |
| Subsequent Product Code | MQP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-10 |
| Decision Date | 2010-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857090422 | K101302 | 000 |
| 10888857090415 | K101302 | 000 |
| 10888857090408 | K101302 | 000 |
| 10888857089976 | K101302 | 000 |
| 10888857089969 | K101302 | 000 |
| 10888857089952 | K101302 | 000 |