The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Unite Reflex Dynamic Discs.
| Device ID | K211612 |
| 510k Number | K211612 |
| Device Name: | Medline UNITE REFLEX Dynamic Discs |
| Classification | Washer, Bolt Nut |
| Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Contact | Jennifer Mason |
| Correspondent | Jennifer Mason Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-26 |
| Decision Date | 2021-12-10 |