The following data is part of a premarket notification filed by Nexxt Spine Llc with the FDA for Inertia Mis Pedicle Screw System.
| Device ID | K132412 |
| 510k Number | K132412 |
| Device Name: | INERTIA MIS PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | NEXXT SPINE LLC 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Contact | Justin Eggleton |
| Correspondent | Justin Eggleton NEXXT SPINE LLC 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-02 |
| Decision Date | 2013-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889929019221 | K132412 | 000 |
| 00889929019146 | K132412 | 000 |
| 00889929019153 | K132412 | 000 |
| 00889929019160 | K132412 | 000 |
| 00889929019177 | K132412 | 000 |
| 00889929019184 | K132412 | 000 |
| 00889929019191 | K132412 | 000 |
| 00889929019207 | K132412 | 000 |
| 00889929019214 | K132412 | 000 |
| 00889929053607 | K132412 | 000 |