510(k) K082617 ยท MNI Orthosis, Spinal Pedicle Fixation
TRAUSON GENERAL SPINAL SYSTEM (GSS)
| Applicant | Trauson (Jiangsu) Medical Instrument Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Jan 15, 2009 |
| Received | Sep 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082617
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.