510(k) K112819 ยท HRS Plate, Fixation, Bone
RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW
| Applicant | Xiamen Double Engline Medical Material Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Dec 16, 2011 |
| Received | Sep 28, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112819
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.