The following data is part of a premarket notification filed by Spineology, Inc. with the FDA for Spineology Facet Screw.
| Device ID | K092464 |
| 510k Number | K092464 |
| Device Name: | SPINEOLOGY FACET SCREW |
| Classification | System, Facet Screw Spinal Device |
| Applicant | SPINEOLOGY, INC. 7200 HUDSON BLVD. N. SUITE 205 St. Paul, MN 55128 |
| Contact | Karen Roche |
| Correspondent | Karen Roche SPINEOLOGY, INC. 7200 HUDSON BLVD. N. SUITE 205 St. Paul, MN 55128 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-11 |
| Decision Date | 2009-11-09 |
| Summary: | summary |