K193256 is an FDA 510(k) clearance for the Anjon Bremer Halo System. This device is classified as a Component, Traction, Invasive (Class II - Special Controls, product code JEC).
Submitted by Anjon Holdings, LLC (Jacksonville, US). The FDA issued a Cleared decision on March 2, 2020, 97 days after receiving the submission on November 26, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K193256 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2019 |
| Decision Date | March 02, 2020 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JEC - Component, Traction, Invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |