K162903 is an FDA 510(k) clearance for the Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies. This device is classified as a Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (Class II - Special Controls, product code KWT).
Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on February 27, 2017, 133 days after receiving the submission on October 17, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3650.
| 510(k) Number | K162903 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 2016 |
| Decision Date | February 27, 2017 |
| Days to Decision | 133 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWT — Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3650 |