The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Excella Ii Spinal System Model Ec2-00.
| Device ID | K102248 |
| 510k Number | K102248 |
| Device Name: | EXCELLA II SPINAL SYSTEM MODEL EC2-00 |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City, UT 84107 |
| Contact | Marshall C Mccarty |
| Correspondent | Marshall C Mccarty INNOVASIS, INC. 614 EAST 3900 SOUTH 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-09 |
| Decision Date | 2010-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M711LS3510 | K102248 | 000 |
| M711LS1890 | K102248 | 000 |
| M711LS1930 | K102248 | 000 |
| M711LS1940 | K102248 | 000 |
| M711LS2080 | K102248 | 000 |
| M711LS2120 | K102248 | 000 |
| M711LS2180 | K102248 | 000 |
| M711E2S65300 | K102248 | 000 |
| M711LS1470 | K102248 | 000 |
| M711LS1530 | K102248 | 000 |
| M711LS1600 | K102248 | 000 |
| M711LS1750 | K102248 | 000 |
| M711LS5630 | K102248 | 000 |
| M711LS5640 | K102248 | 000 |
| M711LS5670 | K102248 | 000 |
| M711LS5680 | K102248 | 000 |
| M711LA1830 | K102248 | 000 |