The following data is part of a premarket notification filed by Incite Innovation Llc with the FDA for Incite Innovation Stand Alone Interbody Fusion Device.
| Device ID | K093808 |
| 510k Number | K093808 |
| Device Name: | INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | INCITE INNOVATION LLC 1350 MAIN STREET, SUITE 1506 Springfield, MA 01103 |
| Contact | John Kirwan |
| Correspondent | John Kirwan INCITE INNOVATION LLC 1350 MAIN STREET, SUITE 1506 Springfield, MA 01103 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-11 |
| Decision Date | 2010-03-24 |
| Summary: | summary |