K171863 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 19, 2018, 270 days after receiving the submission on June 22, 2017.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K171863 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2017 |
| Decision Date | March 19, 2018 |
| Days to Decision | 270 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 |