The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Nile Alternative Fixation Spinal System.
| Device ID | K160208 |
| 510k Number | K160208 |
| Device Name: | NILE Alternative Fixation Spinal System |
| Classification | Bone Fixation Cerclage, Sublaminar |
| Applicant | K2M, Inc. 751 MILLER DRIVE SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M 751 MILLER DRIVE SE Leesburg, VA 20175 |
| Product Code | OWI |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-28 |
| Decision Date | 2016-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857269101 | K160208 | 000 |
| 10888857269095 | K160208 | 000 |
| 10888857269088 | K160208 | 000 |
| 10888857269071 | K160208 | 000 |