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 |