The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Excella Iii-d Spinal Deformity System.
| Device ID | K140238 |
| 510k Number | K140238 |
| Device Name: | EXCELLA III-D SPINAL DEFORMITY SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | INNOVASIS, INC. 614 E 3900 S Salt Lake City, UT 84107 |
| Contact | Mashall Mccarty |
| Correspondent | Mashall Mccarty INNOVASIS, INC. 614 E 3900 S Salt Lake City, UT 84107 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| 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 | 2014-01-30 |
| Decision Date | 2014-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M711E3RC556000 | K140238 | 000 |
| M711E3RC555000 | K140238 | 000 |