The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Nile Proximal Fixation Spinal System.
| Device ID | K161332 |
| 510k Number | K161332 |
| Device Name: | NILE Proximal Fixation Spinal System |
| Classification | Bone Fixation Cerclage, Sublaminar |
| Applicant | K2M, INC. 600 HOPE PARKWAY SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M, INC. 600 HOPE PARKWAY SOUTHEAST 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 | 2016-05-12 |
| Decision Date | 2017-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857384156 | K161332 | 000 |
| 10888857291188 | K161332 | 000 |
| 10888857291195 | K161332 | 000 |
| 10888857291225 | K161332 | 000 |
| 10888857291232 | K161332 | 000 |
| 10888857291249 | K161332 | 000 |
| 10888857291256 | K161332 | 000 |
| 10888857291263 | K161332 | 000 |
| 10888857291270 | K161332 | 000 |
| 10888857291287 | K161332 | 000 |
| 10888857306738 | K161332 | 000 |
| 10888857306745 | K161332 | 000 |
| 10888857291171 | K161332 | 000 |