K063374 is an FDA 510(k) clearance for the NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE. 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 December 6, 2006, 28 days after receiving the submission on November 8, 2006.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3450.
| 510(k) Number | K063374 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2006 |
| Decision Date | December 06, 2006 |
| Days to Decision | 28 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 |