K042458 is an FDA 510(k) clearance for the A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM. This device is classified as a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite (Class II - Special Controls, product code LXT).
Submitted by A.M. Surgical, Inc. (Great Neck, US). The FDA issued a Cleared decision on October 7, 2004, 27 days after receiving the submission on September 10, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K042458 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2004 |
| Decision Date | October 07, 2004 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LXT - Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |