K071863 is an FDA 510(k) clearance for the ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS). This device is classified as a Pin, Fixation, Smooth (Class II - Special Controls, product code HTY).
Submitted by Bioretec, Ltd. (Tampere, FI). The FDA issued a Cleared decision on August 31, 2007, 56 days after receiving the submission on July 6, 2007.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K071863 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2007 |
| Decision Date | August 31, 2007 |
| Days to Decision | 56 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HTY - Pin, Fixation, Smooth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |