The following data is part of a premarket notification filed by Spineology, Inc. with the FDA for Via Spinous Process Fixation System.
| Device ID | K142213 |
| 510k Number | K142213 |
| Device Name: | VIA SPINOUS PROCESS FIXATION SYSTEM |
| Classification | Spinous Process Plate |
| Applicant | SPINEOLOGY, INC. 7800 3RD STREET NORTH Saint Paul, MN 55128 |
| Contact | Tim Crabtree |
| Correspondent | Tim Crabtree SPINEOLOGY, INC. 7800 3RD STREET NORTH Saint Paul, MN 55128 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-12 |
| Decision Date | 2014-09-10 |
| Summary: | summary |