K041393 is an FDA 510(k) clearance for the FASSIER-DUVAL TELSCOPIC IM SYSTEM. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by Pega Medical, Inc. (Montreal (Quebec), CA). The FDA issued a Cleared decision on August 17, 2004, 85 days after receiving the submission on May 24, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K041393 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2004 |
| Decision Date | August 17, 2004 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSB - Rod, Fixation, Intramedullary And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3020 |