K211612 is an FDA 510(k) clearance for the Medline UNITE REFLEX Dynamic Discs. This device is classified as a Washer, Bolt Nut (Class II - Special Controls, product code HTN).
Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on December 10, 2021, 198 days after receiving the submission on May 26, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K211612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2021 |
| Decision Date | December 10, 2021 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HTN — Washer, Bolt Nut |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |