K955780 is an FDA 510(k) clearance for the RIGIDYNE A EXTERNAL FIXATION SYSTEM. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 9, 1996, 50 days after receiving the submission on December 21, 1995.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K955780 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 1995 |
| Decision Date | February 09, 1996 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDW — Pin, Fixation, Threaded |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |