K190290 is an FDA 510(k) clearance for the AltiVate Reverse Humeral Stem, 48mm. This device is classified as a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II - Special Controls, product code KWS).
Submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on April 26, 2019, 74 days after receiving the submission on February 11, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3660.
| 510(k) Number | K190290 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2019 |
| Decision Date | April 26, 2019 |
| Days to Decision | 74 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWS — Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3660 |