The following data is part of a premarket notification filed by Incite Innovation with the FDA for Incite Anchored Cervical Interbody Device.
| Device ID | K150913 |
| 510k Number | K150913 |
| Device Name: | INCITE ANCHORED CERVICAL INTERBODY DEVICE |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | INCITE INNOVATION 1500 MAIN STREET, SUITE 2410 Springfield, MA 01115 -5707 |
| Contact | John Kirwan |
| Correspondent | Renee Murphy ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-06 |
| Decision Date | 2015-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840967123486 | K150913 | 000 |
| 00840180503508 | K150913 | 000 |
| 00840180503515 | K150913 | 000 |
| 00840180503522 | K150913 | 000 |
| 00840180503539 | K150913 | 000 |
| 00840180503546 | K150913 | 000 |
| 00840180503553 | K150913 | 000 |
| 00840180503560 | K150913 | 000 |
| 00840180503577 | K150913 | 000 |
| 00840180503584 | K150913 | 000 |
| 00840180503591 | K150913 | 000 |
| 00840180503492 | K150913 | 000 |