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 |