The following data is part of a premarket notification filed by Altus Partners, Llc with the FDA for Fuji Cervical Plate System.
| Device ID | K183084 |
| 510k Number | K183084 |
| Device Name: | Fuji Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Altus Partners, LLC 1340 Enterprise Drive West Chester, PA 19380 |
| Contact | Mark Melton |
| Correspondent | Mark Melton Altus Partners, LLC 1340 Enterprise Drive West Chester, PA 19380 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-06 |
| Decision Date | 2019-05-29 |