K131298 is an FDA 510(k) clearance for the EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM. This device is classified as a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II - Special Controls, product code HSD).
Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on November 26, 2013, 204 days after receiving the submission on May 6, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3690.
| 510(k) Number | K131298 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2013 |
| Decision Date | November 26, 2013 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3690 |