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 |
|---|---|---|
| M711EP00010 | K071921 | 000 |
| M711EP55500 | K071921 | 000 |
| M711EP55550 | K071921 | 000 |
| M711EP60700 | K071921 | 000 |
| M711EP65300 | K071921 | 000 |
| M711EP65350 | K071921 | 000 |
| M711EP65400 | K071921 | 000 |
| M711EP65450 | K071921 | 000 |
| M711EP65500 | K071921 | 000 |
| M711EP65550 | K071921 | 000 |
| M711EP65600 | K071921 | 000 |
| M711EP70800 | K071921 | 000 |
| M711EP55450 | K071921 | 000 |
| M711EP55400 | K071921 | 000 |
| M711EP00014 | K071921 | 000 |
| M711EP30400 | K071921 | 000 |
| M711EP40500 | K071921 | 000 |
| M711EP45250 | K071921 | 000 |
| M711EP45300 | K071921 | 000 |
| M711EP45350 | K071921 | 000 |
| M711EP45400 | K071921 | 000 |
| M711EP45450 | K071921 | 000 |
| M711EP50600 | K071921 | 000 |
| M711EP55300 | K071921 | 000 |
| M711EP55350 | K071921 | 000 |
| M711EP75300 | K071921 | 000 |
| M711EP75350 | K071921 | 000 |
| M711761000 | K071921 | 000 |
| M711761100 | K071921 | 000 |
| M711761200 | K071921 | 000 |
| M711764600 | K071921 | 000 |
| M711BR6045010 | K071921 | 000 |
| M711BR6055010 | K071921 | 000 |
| M711BR6065010 | K071921 | 000 |
| M711BR6075010 | K071921 | 000 |
| M711BR6085010 | K071921 | 000 |
| M711BR6095010 | K071921 | 000 |
| M711LA1820 | K071921 | 000 |
| M711760900 | K071921 | 000 |
| M711760800 | K071921 | 000 |
| M711EP75400 | K071921 | 000 |
| M711EP75450 | K071921 | 000 |
| M711EP75500 | K071921 | 000 |
| M711EP75550 | K071921 | 000 |
| M711EP75600 | K071921 | 000 |
| M711760400 | K071921 | 000 |
| M711760450 | K071921 | 000 |
| M711760500 | K071921 | 000 |
| M711760550 | K071921 | 000 |
| M711760600 | K071921 | 000 |
| M711760700 | K071921 | 000 |
| M711LS0140 | K071921 | 000 |