K243477 is an FDA 510(k) clearance for the Universal Tendon Spacer. This device is classified as a Prosthesis, Tendon, Passive (Class II - Special Controls, product code HXA).
Submitted by Askorn Medical (Cesson-Sévigné, FR). The FDA issued a Cleared decision on January 10, 2025, 63 days after receiving the submission on November 8, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3025.
| 510(k) Number | K243477 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2024 |
| Decision Date | January 10, 2025 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HXA - Prosthesis, Tendon, Passive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3025 |