The following data is part of a premarket notification filed by Lespine Innovations, Llc with the FDA for Inspan Screwles Fusion System.
| Device ID | K213266 |
| 510k Number | K213266 |
| Device Name: | Inspan ScrewLES Fusion System |
| Classification | Spinous Process Plate |
| Applicant | LESpine Innovations, LLC 350 Main Street, 2nd Floor Malden, MA 02148 |
| Contact | John Sullivan |
| Correspondent | Justin Eggleton MRCA, LLC 803 7th Street NW Washington, DC 20141 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-30 |
| Decision Date | 2021-12-03 |