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 |