The following data is part of a premarket notification filed by Sapphire Medical Group with the FDA for Smg Anterior Cervical Plate System.
| Device ID | K183073 |
| 510k Number | K183073 |
| Device Name: | SMG Anterior Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Sapphire Medical Group 32565 B Golden Lantern Street, Suite 113 Dana Point, CA 92629 |
| Contact | Anthony Ruggiero |
| Correspondent | Anthony Ruggiero Consultant 32565 B Golden Lantern Street, Suite 113 Dana Point, CA 92629 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-05 |
| Decision Date | 2019-02-11 |
| Summary: | summary |