K192097 is an FDA 510(k) clearance for the Exactech® Equinoxe® Stemless Humeral Components. This device is classified as a Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained (Class II - Special Controls, product code PKC).
Submitted by Exactech, Inc. (Gainsville, US). The FDA issued a Cleared decision on April 29, 2020, 268 days after receiving the submission on August 5, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3660. Replacement Of The Humeral Head For Total Anatomic Shoulder Arthroplasty.
| 510(k) Number | K192097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2019 |
| Decision Date | April 29, 2020 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PKC — Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3660 |
| Definition | Replacement Of The Humeral Head For Total Anatomic Shoulder Arthroplasty |