The following data is part of a premarket notification filed by Incite Innovation Llc with the FDA for Incite Anchored Cervical Interbody (aci) Fusion Device.
| Device ID | K122008 |
| 510k Number | K122008 |
| Device Name: | INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-09 |
| Decision Date | 2012-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B038229225 | K122008 | 000 |
| B0382292211 | K122008 | 000 |
| B0382292221 | K122008 | 000 |
| B0382292231 | K122008 | 000 |
| B0382292241 | K122008 | 000 |
| B0382292251 | K122008 | 000 |
| B038229211SHORT1 | K122008 | 000 |
| B038229212LONG1 | K122008 | 000 |
| B038229220 | K122008 | 000 |
| B038229221 | K122008 | 000 |
| B038229222 | K122008 | 000 |
| B038229223 | K122008 | 000 |
| B038229224 | K122008 | 000 |
| B0382292201 | K122008 | 000 |