K883727 is an FDA 510(k) clearance for the BUCKET PROSTHESIS PORP. This device is classified as a Prosthesis, Partial Ossicular Replacement (Class II - Special Controls, product code ETB).
Submitted by Treace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on January 13, 1989, 135 days after receiving the submission on August 31, 1988.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3450.
| 510(k) Number | K883727 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 1988 |
| Decision Date | January 13, 1989 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | ETB — Prosthesis, Partial Ossicular Replacement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3450 |