The following data is part of a premarket notification filed by Spineology, Inc. with the FDA for Spineology Spinous Process Plate.
| Device ID | K123232 |
| 510k Number | K123232 |
| Device Name: | SPINEOLOGY SPINOUS PROCESS PLATE |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SPINEOLOGY, INC. 7800 3RD ST N., SUITE 600 St. Paul, MN 55128 |
| Contact | Bryan Becker |
| Correspondent | Bryan Becker SPINEOLOGY, INC. 7800 3RD ST N., SUITE 600 St. Paul, MN 55128 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-16 |
| Decision Date | 2013-02-07 |
| Summary: | summary |