The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Mis System.
| Device ID | K100605 |
| 510k Number | K100605 |
| Device Name: | MIS SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SPINE WAVE, INC. THREE ENTERPRISE DR. SUITE 210 Shelton, CT 06484 |
| Contact | Denise Duchene |
| Correspondent | Denise Duchene SPINE WAVE, INC. THREE ENTERPRISE DR. SUITE 210 Shelton, CT 06484 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-03 |
| Decision Date | 2010-06-04 |
| Summary: | summary |