K060560 is an FDA 510(k) clearance for the ASCENSION PYROSPHERE CMC/TMT. 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 May 5, 2006, 64 days after receiving the submission on March 2, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3730.
| 510(k) Number | K060560 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2006 |
| Decision Date | May 05, 2006 |
| Days to Decision | 64 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 |