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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M7404400046 | K142213 | 000 |
| M7404400022 | K142213 | 000 |
| M7404400021 | K142213 | 000 |
| M7404400020 | K142213 | 000 |
| M7404400019 | K142213 | 000 |
| M7404400018 | K142213 | 000 |
| M7404400015 | K142213 | 000 |
| M7404400014 | K142213 | 000 |
| M7404400013 | K142213 | 000 |
| M7404400012 | K142213 | 000 |
| M7404400011 | K142213 | 000 |
| M7404400006 | K142213 | 000 |
| M7404400005 | K142213 | 000 |
| M7404400004 | K142213 | 000 |
| M7404400003 | K142213 | 000 |
| M7404400002 | K142213 | 000 |
| M7404400023 | K142213 | 000 |
| M7404400024 | K142213 | 000 |
| M7404400042 | K142213 | 000 |
| M7404400041 | K142213 | 000 |
| M7404400040 | K142213 | 000 |
| M7404400039 | K142213 | 000 |
| M7404400038 | K142213 | 000 |
| M7404400037 | K142213 | 000 |
| M7404400036 | K142213 | 000 |
| M7404400035 | K142213 | 000 |
| M7404400034 | K142213 | 000 |
| M7404400033 | K142213 | 000 |
| M7404400032 | K142213 | 000 |
| M7404400030 | K142213 | 000 |
| M7404400028 | K142213 | 000 |
| M7404400027 | K142213 | 000 |
| M7404400026 | K142213 | 000 |
| M7404400001 | K142213 | 000 |