The following data is part of a premarket notification filed by Incite Innovation Llc with the FDA for Incite Anchored Cervical Interbody Device.
| Device ID | K130306 |
| 510k Number | K130306 |
| Device Name: | INCITE ANCHORED CERVICAL INTERBODY DEVICE |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | INCITE INNOVATION LLC 1500 MAIN STREET STE. 2410 Springfield, MA 01115 |
| Contact | John Kirwan |
| Correspondent | John Kirwan INCITE INNOVATION LLC 1500 MAIN STREET STE. 2410 Springfield, MA 01115 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-07 |
| Decision Date | 2013-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B038227225 | K130306 | 000 |
| B0382272211 | K130306 | 000 |
| B0382272221 | K130306 | 000 |
| B0382272231 | K130306 | 000 |
| B0382272241 | K130306 | 000 |
| B0382272251 | K130306 | 000 |
| B038227220 | K130306 | 000 |
| B038227221 | K130306 | 000 |
| B038227222 | K130306 | 000 |
| B038227223 | K130306 | 000 |
| B038227224 | K130306 | 000 |
| B0382272201 | K130306 | 000 |