K060518 is an FDA 510(k) clearance for the PARTIAL OSSICULAR REPLACEMENT PROSTHESES. This device is classified as a Prosthesis, Partial Ossicular Replacement (Class II - Special Controls, product code ETB).
Submitted by Grace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on June 28, 2006, 121 days after receiving the submission on February 27, 2006.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3450.
| 510(k) Number | K060518 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2006 |
| Decision Date | June 28, 2006 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETB - Prosthesis, Partial Ossicular Replacement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3450 |