K193122 is an FDA 510(k) clearance for the Biocore9 Humeral Resurfacing System. This device is classified as a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II - Special Controls, product code HSD).
Submitted by Biocore9, LLC (Whippany, US). The FDA issued a Cleared decision on May 15, 2020, 185 days after receiving the submission on November 12, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3690.
| 510(k) Number | K193122 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2019 |
| Decision Date | May 15, 2020 |
| Days to Decision | 185 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 |