The following data is part of a premarket notification filed by Meditech Spine, Llc with the FDA for Cure 2.0 Anterior Cervical Plate (acp) System.
| Device ID | K210286 |
| 510k Number | K210286 |
| Device Name: | Cure 2.0 Anterior Cervical Plate (ACP) System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Meditech Spine, LLC 1447 Peachtree St NE Suite 440 Atlanta, GA 30309 |
| Contact | Bruce Dunaway |
| Correspondent | Bruce Dunaway Meditech Spine, LLC 1447 Peachtree St NE Suite 440 Atlanta, GA 30309 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-02 |
| Decision Date | 2021-03-18 |