K041451 is an FDA 510(k) clearance for the ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50. This device is classified as a Prosthesis, Wrist, Carpal Trapezium (Class II - Special Controls, product code KYI).
Submitted by Ascension Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on August 25, 2004, 85 days after receiving the submission on June 1, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3770.
| 510(k) Number | K041451 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2004 |
| Decision Date | August 25, 2004 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KYI — Prosthesis, Wrist, Carpal Trapezium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3770 |