The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Nile Alternative Fixation.
| Device ID | K143350 |
| 510k Number | K143350 |
| Device Name: | Nile Alternative Fixation |
| Classification | Bone Fixation Cerclage, Sublaminar |
| Applicant | K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 |
| Product Code | OWI |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-24 |
| Decision Date | 2015-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857157699 | K143350 | 000 |
| 10888857157682 | K143350 | 000 |
| 10888857156371 | K143350 | 000 |
| 10888857156364 | K143350 | 000 |
| 10888857111608 | K143350 | 000 |
| 10888857111592 | K143350 | 000 |
| 10888857047716 | K143350 | 000 |
| 10888857000025 | K143350 | 000 |
| 10888857000018 | K143350 | 000 |