The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Pfx Spinous Process Fixation System.
| Device ID | K132765 |
| 510k Number | K132765 |
| Device Name: | PFX SPINOUS PROCESS FIXATION SYSTEM |
| Classification | Spinous Process Plate |
| Applicant | INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City, UT 84107 |
| Contact | Marshall Mccarty |
| Correspondent | Marshall Mccarty INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City, UT 84107 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-04 |
| Decision Date | 2014-07-14 |
| Summary: | summary |