The following data is part of a premarket notification filed by Indius Medical Technologies Pvt. Ltd. with the FDA for Sea-link Anterior Cervical Plate System.
| Device ID | K200224 |
| 510k Number | K200224 |
| Device Name: | SEA-LINK Anterior Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Indius Medical Technologies Pvt. Ltd. Unit 12, Floors 1 And 2, Electronic Co-Operative Estate Pune Satara Road Pune, IN 411009 |
| Contact | Aditya Ingalhalikar |
| Correspondent | Nathan Wright Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-29 |
| Decision Date | 2020-03-24 |