The following data is part of a premarket notification filed by Accelerated Innovation, Llc with the FDA for Accin Anterior Cervical Plate System.
| Device ID | K073530 |
| 510k Number | K073530 |
| Device Name: | ACCIN ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | ACCELERATED INNOVATION, LLC 1033 US HIGHWAY 46 EAST SUITE A204 Clifton, NJ 07013 |
| Contact | Michael Kvitnitsky |
| Correspondent | Michael Kvitnitsky ACCELERATED INNOVATION, LLC 1033 US HIGHWAY 46 EAST SUITE A204 Clifton, NJ 07013 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-17 |
| Decision Date | 2008-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B41711604891 | K073530 | 000 |
| B41711604861 | K073530 | 000 |
| B41711604831 | K073530 | 000 |
| B41711604801 | K073530 | 000 |
| B41711604771 | K073530 | 000 |
| B41711604741 | K073530 | 000 |
| B41711602351 | K073530 | 000 |
| B41711601181 | K073530 | 000 |