The following data is part of a premarket notification filed by Intelligent Implant Systems, Llc with the FDA for Revolution Spinal Fixation System.
| Device ID | K160216 |
| 510k Number | K160216 |
| Device Name: | Revolution Spinal Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | INTELLIGENT IMPLANT SYSTEMS, LLC 3300 INTERNATIONAL AIRPORT DRIVE; STE 1100 Charlotte, NC 28208 |
| Contact | Michael Nutt |
| Correspondent | Michael Nutt INTELLIGENT IMPLANT SYSTEMS, LLC 3300 INTERNATIONAL AIRPORT DRIVE; STE 1100 Charlotte, NC 28208 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-29 |
| Decision Date | 2016-04-22 |
| Summary: | summary |