K926213 is an FDA 510(k) clearance for the MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by Osteo Technology, Inc. (Timonium, US). The FDA issued a Cleared decision on June 17, 1993, 189 days after receiving the submission on December 10, 1992.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K926213 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 1992 |
| Decision Date | June 17, 1993 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | HSB — Rod, Fixation, Intramedullary And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3020 |