The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Innovasis Excella Spinal System, Excella-m (monoaxial Screws), Excella-p (polyaxial Screws).
| Device ID | K071921 |
| 510k Number | K071921 |
| Device Name: | INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS) |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City, UT 84107 |
| Contact | Warren Dansie |
| Correspondent | Warren Dansie INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City, UT 84107 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-12 |
| Decision Date | 2007-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M711LS0140 | K071921 | 000 |
| M711LA1820 | K071921 | 000 |