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 | K142939 |
| 510k Number | K142939 |
| Device Name: | Revolution Spinal Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | INTELLIGENT IMPLANT SYSTEMS, LLC 3300 INTERNATIONAL AIRPORT DRIVE SUITE 1100 Charlotte, NC 28208 |
| Contact | Michael Nutt |
| Correspondent | Michael Nutt INTELLIGENT IMPLANT SYSTEMS, LLC 3300 INTERNATIONAL AIRPORT DRIVE SUITE 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 | 2014-10-09 |
| Decision Date | 2015-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814033020009 | K142939 | 000 |
| 00814033020122 | K142939 | 000 |
| 00814033020139 | K142939 | 000 |
| 00814033020146 | K142939 | 000 |
| 00814033020153 | K142939 | 000 |
| 00814033020160 | K142939 | 000 |
| 00814033020177 | K142939 | 000 |
| 00814033020184 | K142939 | 000 |
| 00814033020191 | K142939 | 000 |
| 00814033020115 | K142939 | 000 |
| 00814033020108 | K142939 | 000 |
| 00814033020092 | K142939 | 000 |
| 00814033020016 | K142939 | 000 |
| 00814033020023 | K142939 | 000 |
| 00814033020030 | K142939 | 000 |
| 00814033020047 | K142939 | 000 |
| 00814033020054 | K142939 | 000 |
| 00814033020061 | K142939 | 000 |
| 00814033020078 | K142939 | 000 |
| 00814033020085 | K142939 | 000 |
| 00814033020207 | K142939 | 000 |
| 00814033020214 | K142939 | 000 |
| 00814033020610 | K142939 | 000 |
| 00814033020627 | K142939 | 000 |
| 00814033020665 | K142939 | 000 |
| 00814033020672 | K142939 | 000 |
| 00814033020689 | K142939 | 000 |
| 00814033020863 | K142939 | 000 |
| 00814033020870 | K142939 | 000 |
| 00814033020887 | K142939 | 000 |
| 00814033020320 | K142939 | 000 |
| 00814033020313 | K142939 | 000 |
| 00814033020306 | K142939 | 000 |
| 00814033020221 | K142939 | 000 |
| 00814033020238 | K142939 | 000 |
| 00814033020245 | K142939 | 000 |
| 00814033020252 | K142939 | 000 |
| 00814033020269 | K142939 | 000 |
| 00814033020276 | K142939 | 000 |
| 00814033020283 | K142939 | 000 |
| 00814033020290 | K142939 | 000 |
| 00814033020894 | K142939 | 000 |