The following data is part of a premarket notification filed by N-spine, Inc. with the FDA for Nfix Fusion System.
| Device ID | K053623 |
| 510k Number | K053623 |
| Device Name: | NFIX FUSION SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | N-SPINE, INC. P.O. BOX 560 Stillwater, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan N-SPINE, INC. P.O. BOX 560 Stillwater, MN 55082 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-28 |
| Decision Date | 2006-07-12 |
| Summary: | summary |