K230444 is an FDA 510(k) clearance for the Talee, Talee PostOp. This device is classified as a Orthosis, Cranial (Class II - Special Controls, product code MVA).
Submitted by Invent Medical USA, LLC (Warminster, US). The FDA issued a Cleared decision on June 22, 2023, 121 days after receiving the submission on February 21, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5970.
| 510(k) Number | K230444 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 2023 |
| Decision Date | June 22, 2023 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | MVA — Orthosis, Cranial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5970 |