510(k) K131609 ยท HSB Rod, Fixation, Intramedullary And Accessories
DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM
| Applicant | Xiamen Double Engine Medical Material Co., Ltd., Xiamen, Fujian, CN |
| Decision | Substantially Equivalent, May 21, 2014 |
| Received | Jun 3, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131609
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.