K092047 is an FDA 510(k) clearance for the ASCENSION METAL GREAT TOE SYSTEM. This device is classified as a Prosthesis, Toe, Hemi-, Phalangeal (Class II - Special Controls, product code KWD).
Submitted by Ascension Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on January 14, 2010, 192 days after receiving the submission on July 6, 2009.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3730.
| 510(k) Number | K092047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2009 |
| Decision Date | January 14, 2010 |
| Days to Decision | 192 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWD — Prosthesis, Toe, Hemi-, Phalangeal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3730 |