The following data is part of a premarket notification filed by Spinal Innovations, Inc. with the FDA for Revolution Spinal Fixation System.
| Device ID | K032219 |
| 510k Number | K032219 |
| Device Name: | REVOLUTION SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SPINAL INNOVATIONS, INC. 7850 STAGE HILLS BLVD. SUITE 105 Bartlett, TN 38133 -4029 |
| Contact | Joe Clift |
| Correspondent | Joe Clift SPINAL INNOVATIONS, INC. 7850 STAGE HILLS BLVD. SUITE 105 Bartlett, TN 38133 -4029 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-21 |
| Decision Date | 2003-12-19 |
| Summary: | summary |