K080070 is an FDA 510(k) clearance for the K-HELIX PISTON AND PORP 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 April 17, 2008, 98 days after receiving the submission on January 10, 2008.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3450.
| 510(k) Number | K080070 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 2008 |
| Decision Date | April 17, 2008 |
| Days to Decision | 98 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 |