K012190 is an FDA 510(k) clearance for the AOS MODULAR FEMORAL NAIL. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by Advanced Orthopaedic Solutions, Inc. (San Pedro, US). The FDA issued a Cleared decision on September 24, 2001, 73 days after receiving the submission on July 13, 2001.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K012190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2001 |
| Decision Date | September 24, 2001 |
| Days to Decision | 73 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 |