The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Excella-m Spinal System.
| Device ID | K042143 |
| 510k Number | K042143 |
| Device Name: | EXCELLA-M SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | INNOVASIS, INC. 997 EAST 3900 SOUTH SUITE 103 Salt Lake City, UT 84124 |
| Contact | Brent A Felix |
| Correspondent | Brent A Felix INNOVASIS, INC. 997 EAST 3900 SOUTH SUITE 103 Salt Lake City, UT 84124 |
| Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-09 |
| Decision Date | 2004-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M711LA170010 | K042143 | 000 |
| M71100065350 | K042143 | 000 |
| M71100065300 | K042143 | 000 |
| M71100055600 | K042143 | 000 |
| M71100055550 | K042143 | 000 |
| M71100055500 | K042143 | 000 |
| M71100055450 | K042143 | 000 |
| M71100055400 | K042143 | 000 |
| M71100055350 | K042143 | 000 |
| M71100055300 | K042143 | 000 |
| M71100065400 | K042143 | 000 |
| M71100065450 | K042143 | 000 |
| M71100065500 | K042143 | 000 |
| M71100075600 | K042143 | 000 |
| M71100075550 | K042143 | 000 |
| M71100075500 | K042143 | 000 |
| M71100075450 | K042143 | 000 |
| M71100075400 | K042143 | 000 |
| M71100075350 | K042143 | 000 |
| M71100075300 | K042143 | 000 |
| M71100065600 | K042143 | 000 |
| M71100065550 | K042143 | 000 |
| M711610000 | K042143 | 000 |